The Experts below are selected from a list of 309 Experts worldwide ranked by ideXlab platform
Timothy J Craig - One of the best experts on this subject based on the ideXlab platform.
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the role of montelukast on perennial allergic rhinitis and associated sleep disturbances and daytime Somnolence
Allergy and Asthma Proceedings, 2008Co-Authors: Carah B Santos, Erik Lehman, Christopher Hanks, Jeffrey Mccann, E L Pratt, Timothy J CraigAbstract:: Perennial allergic rhinitis (PAR) often causes sleep disturbances and associated daytime Somnolence, thus resulting in a poor quality of life. Various clinical interventions in patients suffering from the disorder seek to improve symptoms and quality of life. Additional studies are needed to establish whether the alleviation of PAR symptoms, particularly the reduction of congestion, will improve sleep quality and reduce daytime Somnolence. This study seeks to determine whether treatment with montelukast is more effective than placebo in reducing nasal congestion and sleep disturbances, resulting in reduced daytime Somnolence and fatigue in patients with PAR. Thirty-one subjects were enrolled in a double-blinded, placebo-controlled study using Balaam's design. Patients were treated with montelukast or placebo. Collected subjective data included a daily diary recording nasal symptoms, sleep issues, and daytime fatigue, the Functional Outcomes of Sleep Questionnaire, the Epworth Sleepiness Scale, Juniper's Rhinoconjunctivitis Quality of Life Questionnaire, the Rhinitis Severity Scale, the Calgary Sleep Apnea Quality of Life Index, and Trail Making tests. Subjects treated with montelukast, compared with placebo, showed a statistically significant improvement in daytime Somnolence (p = 0.0089) and daytime fatigue (p = 0.0087), with both factors improving with montelukast and worsening with placebo. In a small cohort of subjects, montelukast, when compared with placebo, improved the symptoms of PAR and reduced the fatigue and daytime Somnolence associated with the disorder.
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how do topical nasal corticosteroids improve sleep and daytime Somnolence in allergic rhinitis
The Journal of Allergy and Clinical Immunology, 2005Co-Authors: Timothy J Craig, Christopher Hanks, L H FisherAbstract:Therapy for rhinitis improves sleep quality and symptoms of daytime sleepiness. This improvement with therapy may be secondary to anti-inflammatory effects, leading to a reduction of inflammatory mediators, or to a mechanical reduction of congestion directly leading to improvement in sleep disturbance. We combined our data from 3 placebo-controlled studies of intranasal corticosteroids in patients with perennial rhinitis to determine whether a correlation between the reduction of congestion and improved sleep and daytime Somnolence existed. The pooled data of budesonide, flunisolide, and fluticasone demonstrated significantly decreased nasal congestion, sleep problems, and sleepiness in treated patients. The data demonstrated a correlation between a reduction in nasal congestion and an improvement of sleep ( P P = .01). Thus, topical intranasal corticosteroids should be used to decrease nasal congestion and to improve sleep and daytime Somnolence in patients manifesting these symptoms.
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the effect of intranasal steroid budesonide on the congestion related sleep disturbance and daytime Somnolence in patients with perennial allergic rhinitis
Allergy and Asthma Proceedings, 2005Co-Authors: F Gurevich, Casey Glass, Michael J Davies, Jeffery Mccann, L H Fisher, S Chegini, Cathy Mende, Timothy J CraigAbstract:Abstract Patients with perennial allergic rhinitis (PAR) often present with nasal congestion, poor sleep, daytime fatigue, and daytime Somnolence. Pharmacologic therapy that reduces nasal congestion should improve the PAR patients' sleep quality and reduce daytime Somnolence and fatigue. Our hypothesis is that intranasal steroid budesonide (BUD), an effective topical anti-inflammatory agent, will reduce nasal congestion and improve the patients' quality of life. The objective of this study was to determine whether topical steroid BUD improves sleep, daytime Somnolence, and fatigue in patients with PAR. Twenty-six subjects were enrolled in a double-blind, placebo-controlled, crossover study using Balaam's design. Patients were treated with intranasal steroid spray BUD or placebo. The Epworth Sleepiness Scale, daily diary, and questionnaires were used as tools for subjective data analysis, which focused on nasal symptoms, sleep quality, daytime Somnolence, and fatigue. The results were summarized and compared by PROC MIXED in SAS. The daily diary data showed significant improvement in self-reported nasal congestion (p = 0.04) and daytime sleepiness (p = 0.01) and a trend in reduction of daytime fatigue (p = 0.08) in the BUD group compared with the placebo group. The sleep measures showed statistically significant improvement in total sleep measures score (p = 0.04), "sleep compared with absolute" (p = 0.01), and "refreshing and restorative" sleep (p = 0.04) in the active group. Nasal corticosteroid BUD is effective in reducing nasal congestion, daytime Somnolence, and daytime fatigue, and improving sleep quality in PAR.
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efficacy of the topical nasal steroid budesonide on improving sleep and daytime Somnolence in patients with perennial allergic rhinitis
Allergy, 2003Co-Authors: Kathleen Hughes, Erik Lehman, F Gurevich, Casey Glass, L H Fisher, M Ripchinski, T E Weaver, Timothy J CraigAbstract:Background: Improving quality of life is considered to be a major endpoint and motivation for clinical intervention in patients with perennial allergic rhinitis (PAR). In addition to classical symptoms of congestion, pruritus, and rhinorrhea, patients will often complain of not being able to sleep well at night and of feeling fatigued during the day. Like sleep apnea, PAR has also been shown to cause sleep disturbance and consequently worsen daytime fatigue and Somnolence. Hypothesis: It is proposed that by decreasing nasal obstruction due to allergic rhinitis by treating with the topical steroid budesonide, symptoms of daytime fatigue and Somnolence can be improved. Methods: Twenty-two subjects were enrolled in a double-blind, placebo-controlled, crossover study using Baalam's design. Patients were treated with either budesonide 128 μg/day or placebo. Subjective data include the Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Rhino-conjunctivitis Quality of Life Questionnaire, and a daily diary recording nasal symptoms, sleep problems, and daytime fatigue. Results: The results illustrated that the topical nasal corticosteroid significantly improved daytime fatigue (P = 0.03), Somnolence (P = 0.02), and quality of sleep (P = 0.05) compared to placebo in patients suffering from PAR. Summary: Budesonide is able to improve congestion, sleep, and daytime Somnolence.
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the effect of topical nasal fluticasone on objective sleep testing and the symptoms of rhinitis sleep and daytime Somnolence in perennial allergic rhinitis
Allergy and Asthma Proceedings, 2003Co-Authors: Timothy J Craig, Erik Lehman, Sujani Kakumanu, Cathy Mende, Kathleen Hughes, Vernon M ChinchilliAbstract:: Recent data suggested that daytime Somnolence in patients with allergic rhinitis was secondary to disrupted sleep caused by nasal congestion. Medications, which decreased congestion, would be expected to improve sleep and daytime Somnolence. Previously, we showed that nasal steroids improved all three symptoms. Presently, we have not performed objective sleep testing to determine if there is a correlation between subjective improvement of congestion, sleep, and daytime Somnolence. The objective of this 8-week, double-blind, placebo-controlled study was to determine if topical nasal fluticasone is effective at decreasing subjective congestion and daytime Somnolence and improving sleep and if this improvement correlated with a change in overnight sleep testing (polysomnography). We recruited 32 subjects with perennial allergic rhinitis and randomized them in a double-blinded, cross-over fashion, to receive placebo or fluticasone (50 micrograms a spray), 2 sprays each side everyday, using Balaam's design. Questionnaires, quality of life instruments, daily diary, Epworth Sleepiness Scale, and an overnight sleep test with polysomnograms were used as tools. The last 2 weeks of each 4-week treatment period were summarized, scored, and compared by PROC MIXED in SAS. Correlations between arousals on sleep tests and subjective tests were performed. Fluticasone improved subjective sleep when compared with placebo (p = 0.04); however, there was no difference in the apnea/hypopnea index in those that were treated. Daytime sleepiness and fatigue were decreased by > 10% in the treated group; however, this was not statistically significant. However, fluticasone used at approved doses improves subjective sleep in patients with perennial allergic rhinitis without a change in the apnea/hypopnea index.
Jacques G. Verly - One of the best experts on this subject based on the ideXlab platform.
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EMBC - EVALUATION OF THE PERFORMANCE OF AN EXPERIMENTAL Somnolence QUANTIFICATION SYSTEM IN TERMS OF REACTION TIMES AND LAPSES
Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and, 2014Co-Authors: Clémentine François, Jérôme Wertz, Murielle Kirkove, Jacques G. VerlyAbstract:Somnolence is known to be a major cause of various types of accidents, and ocular parameters are recognized to be reliable physiological indicators of Somnolence. We have thus developed an experimental Somnolence quantification system that uses images of the eye and that produces a level of Somnolence on a continuous numerical scale. The aim of this paper is to show that the level of Somnolence produced by our system is well related to the level of performance of subjects accomplishing three reaction-time tests in different sleep conditions. Twenty seven subjects participated in the study and images of their right eye were continuously recorded during the tests. Levels of Somnolence, reaction times (RTs), and percentages of lapses were computed for each minute of test. Results show that the values of these three parameters increase significantly with sleep deprivation. We determined the best threshold on our scale of Somnolence to predict lapses, and we also shown that correlations exist with some of the ocular parameters. Our Somnolence quantification system has thus significant potential to predict performance decrements of subjects accomplishing a task.
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Preliminary evaluation of an experimental Somnolence quantification system based on images of the eye
2014Co-Authors: Clémentine François, Jérôme Wertz, Murielle Kirkove, David Grogna, Thomas Hoyoux, Thomas Langohr, Philippe Latour, Jacques G. VerlyAbstract:Somnolence is known to be a major cause of various types of accidents, particularly on roads, and ocular parameters are recognized to be good and reliable physiological indicators of Somnolence. We have thus developed an experimental (software) system that uses ocular parameters extracted from images of the eye to produce a level of Somnolence on a continuous numerical scale. The ultimate goal of this system is to prevent Somnolence-related accidents.
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Evaluation of the performance of an experimental Somnolence quantification system in terms of reaction times and lapses
2014 36th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 2014Co-Authors: Clémentine François, Jérôme Wertz, Murielle Kirkove, Jacques G. VerlyAbstract:Somnolence is known to be a major cause of various types of accidents, and ocular parameters are recognized to be reliable physiological indicators of Somnolence. We have thus developed an experimental Somnolence quantification system that uses images of the eye and that produces a level of Somnolence on a continuous numerical scale. The aim of this paper is to show that the level of Somnolence produced by our system is well related to the level of performance of subjects accomplishing three reaction-time tests in different sleep conditions. Twenty seven subjects participated in the study and images of their right eye were continuously recorded during the tests. Levels of Somnolence, reaction times (RTs), and percentages of lapses were computed for each minute of test. Results show that the values of these three parameters increase significantly with sleep deprivation. We determined the best threshold on our scale of Somnolence to predict lapses, and we also shown that correlations exist with some of the ocular parameters. Our Somnolence quantification system has thus significant potential to predict performance decrements of subjects accomplishing a task.
Erik Lehman - One of the best experts on this subject based on the ideXlab platform.
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the role of montelukast on perennial allergic rhinitis and associated sleep disturbances and daytime Somnolence
Allergy and Asthma Proceedings, 2008Co-Authors: Carah B Santos, Erik Lehman, Christopher Hanks, Jeffrey Mccann, E L Pratt, Timothy J CraigAbstract:: Perennial allergic rhinitis (PAR) often causes sleep disturbances and associated daytime Somnolence, thus resulting in a poor quality of life. Various clinical interventions in patients suffering from the disorder seek to improve symptoms and quality of life. Additional studies are needed to establish whether the alleviation of PAR symptoms, particularly the reduction of congestion, will improve sleep quality and reduce daytime Somnolence. This study seeks to determine whether treatment with montelukast is more effective than placebo in reducing nasal congestion and sleep disturbances, resulting in reduced daytime Somnolence and fatigue in patients with PAR. Thirty-one subjects were enrolled in a double-blinded, placebo-controlled study using Balaam's design. Patients were treated with montelukast or placebo. Collected subjective data included a daily diary recording nasal symptoms, sleep issues, and daytime fatigue, the Functional Outcomes of Sleep Questionnaire, the Epworth Sleepiness Scale, Juniper's Rhinoconjunctivitis Quality of Life Questionnaire, the Rhinitis Severity Scale, the Calgary Sleep Apnea Quality of Life Index, and Trail Making tests. Subjects treated with montelukast, compared with placebo, showed a statistically significant improvement in daytime Somnolence (p = 0.0089) and daytime fatigue (p = 0.0087), with both factors improving with montelukast and worsening with placebo. In a small cohort of subjects, montelukast, when compared with placebo, improved the symptoms of PAR and reduced the fatigue and daytime Somnolence associated with the disorder.
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efficacy of the topical nasal steroid budesonide on improving sleep and daytime Somnolence in patients with perennial allergic rhinitis
Allergy, 2003Co-Authors: Kathleen Hughes, Erik Lehman, F Gurevich, Casey Glass, L H Fisher, M Ripchinski, T E Weaver, Timothy J CraigAbstract:Background: Improving quality of life is considered to be a major endpoint and motivation for clinical intervention in patients with perennial allergic rhinitis (PAR). In addition to classical symptoms of congestion, pruritus, and rhinorrhea, patients will often complain of not being able to sleep well at night and of feeling fatigued during the day. Like sleep apnea, PAR has also been shown to cause sleep disturbance and consequently worsen daytime fatigue and Somnolence. Hypothesis: It is proposed that by decreasing nasal obstruction due to allergic rhinitis by treating with the topical steroid budesonide, symptoms of daytime fatigue and Somnolence can be improved. Methods: Twenty-two subjects were enrolled in a double-blind, placebo-controlled, crossover study using Baalam's design. Patients were treated with either budesonide 128 μg/day or placebo. Subjective data include the Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Rhino-conjunctivitis Quality of Life Questionnaire, and a daily diary recording nasal symptoms, sleep problems, and daytime fatigue. Results: The results illustrated that the topical nasal corticosteroid significantly improved daytime fatigue (P = 0.03), Somnolence (P = 0.02), and quality of sleep (P = 0.05) compared to placebo in patients suffering from PAR. Summary: Budesonide is able to improve congestion, sleep, and daytime Somnolence.
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the effect of topical nasal fluticasone on objective sleep testing and the symptoms of rhinitis sleep and daytime Somnolence in perennial allergic rhinitis
Allergy and Asthma Proceedings, 2003Co-Authors: Timothy J Craig, Erik Lehman, Sujani Kakumanu, Cathy Mende, Kathleen Hughes, Vernon M ChinchilliAbstract:: Recent data suggested that daytime Somnolence in patients with allergic rhinitis was secondary to disrupted sleep caused by nasal congestion. Medications, which decreased congestion, would be expected to improve sleep and daytime Somnolence. Previously, we showed that nasal steroids improved all three symptoms. Presently, we have not performed objective sleep testing to determine if there is a correlation between subjective improvement of congestion, sleep, and daytime Somnolence. The objective of this 8-week, double-blind, placebo-controlled study was to determine if topical nasal fluticasone is effective at decreasing subjective congestion and daytime Somnolence and improving sleep and if this improvement correlated with a change in overnight sleep testing (polysomnography). We recruited 32 subjects with perennial allergic rhinitis and randomized them in a double-blinded, cross-over fashion, to receive placebo or fluticasone (50 micrograms a spray), 2 sprays each side everyday, using Balaam's design. Questionnaires, quality of life instruments, daily diary, Epworth Sleepiness Scale, and an overnight sleep test with polysomnograms were used as tools. The last 2 weeks of each 4-week treatment period were summarized, scored, and compared by PROC MIXED in SAS. Correlations between arousals on sleep tests and subjective tests were performed. Fluticasone improved subjective sleep when compared with placebo (p = 0.04); however, there was no difference in the apnea/hypopnea index in those that were treated. Daytime sleepiness and fatigue were decreased by > 10% in the treated group; however, this was not statistically significant. However, fluticasone used at approved doses improves subjective sleep in patients with perennial allergic rhinitis without a change in the apnea/hypopnea index.
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effect of topical nasal azelastine on the symptoms of rhinitis sleep and daytime Somnolence in perennial allergic rhinitis
Annals of Allergy Asthma & Immunology, 2000Co-Authors: Stanley Golden, S Teets, Erik Lehman, Elizabeth A Mauger, Vernon M Chinchilli, Joshua M Berlin, Sujani Kakumanu, Timothy Lucus, Timothy J CraigAbstract:Background Recent data suggested that daytime Somnolence in patients with allergic rhinitis was secondary to disrupted sleep caused by nasal congestion. Medications, which decreased congestion, would be expected to improve sleep and daytime Somnolence. Previously, we demonstrated that nasal steroids improved all three symptoms. The effect of topical nasal antihistamines on these symptoms has yet to be studied. Objective The objective of this 8-week, double-blind, placebo-controlled study was to determine whether topical nasal azelastine was effective at decreasing congestion, daytime Somnolence, and improving sleep. Methods We recruited 24 subjects with perennial allergic rhinitis and randomized them in a double-blinded, crossover fashion, to receive placebo or azelastine two sprays BID, using Balaam's design. Questionnaires, daily diary, and Epworth Sleepiness Scale were used as tools. The last 2 weeks of each 4-week treatment period were summarized, scored, and compared by PROC MIXED in SAS. Results The analysis of the Rhinitis Severity Score showed significant improvement only of rhinorrhea in the azelastine group ( P = .03). The symptom severity of nasal congestion and daytime Somnolence was not significantly different between placebo and azelastine. Subjects considered azelastine effective at improving their sleep ( P = .04), but daytime Somnolence ( P = .06) and congestion ( P = .09) were not statistically improved. Conclusion Azelastine is effective in reducing rhinorrhea and improving sleep quality. We were unable to demonstrate that azelastine can significantly reduce the severity of congestion or daytime Somnolence.
L H Fisher - One of the best experts on this subject based on the ideXlab platform.
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how do topical nasal corticosteroids improve sleep and daytime Somnolence in allergic rhinitis
The Journal of Allergy and Clinical Immunology, 2005Co-Authors: Timothy J Craig, Christopher Hanks, L H FisherAbstract:Therapy for rhinitis improves sleep quality and symptoms of daytime sleepiness. This improvement with therapy may be secondary to anti-inflammatory effects, leading to a reduction of inflammatory mediators, or to a mechanical reduction of congestion directly leading to improvement in sleep disturbance. We combined our data from 3 placebo-controlled studies of intranasal corticosteroids in patients with perennial rhinitis to determine whether a correlation between the reduction of congestion and improved sleep and daytime Somnolence existed. The pooled data of budesonide, flunisolide, and fluticasone demonstrated significantly decreased nasal congestion, sleep problems, and sleepiness in treated patients. The data demonstrated a correlation between a reduction in nasal congestion and an improvement of sleep ( P P = .01). Thus, topical intranasal corticosteroids should be used to decrease nasal congestion and to improve sleep and daytime Somnolence in patients manifesting these symptoms.
-
the effect of intranasal steroid budesonide on the congestion related sleep disturbance and daytime Somnolence in patients with perennial allergic rhinitis
Allergy and Asthma Proceedings, 2005Co-Authors: F Gurevich, Casey Glass, Michael J Davies, Jeffery Mccann, L H Fisher, S Chegini, Cathy Mende, Timothy J CraigAbstract:Abstract Patients with perennial allergic rhinitis (PAR) often present with nasal congestion, poor sleep, daytime fatigue, and daytime Somnolence. Pharmacologic therapy that reduces nasal congestion should improve the PAR patients' sleep quality and reduce daytime Somnolence and fatigue. Our hypothesis is that intranasal steroid budesonide (BUD), an effective topical anti-inflammatory agent, will reduce nasal congestion and improve the patients' quality of life. The objective of this study was to determine whether topical steroid BUD improves sleep, daytime Somnolence, and fatigue in patients with PAR. Twenty-six subjects were enrolled in a double-blind, placebo-controlled, crossover study using Balaam's design. Patients were treated with intranasal steroid spray BUD or placebo. The Epworth Sleepiness Scale, daily diary, and questionnaires were used as tools for subjective data analysis, which focused on nasal symptoms, sleep quality, daytime Somnolence, and fatigue. The results were summarized and compared by PROC MIXED in SAS. The daily diary data showed significant improvement in self-reported nasal congestion (p = 0.04) and daytime sleepiness (p = 0.01) and a trend in reduction of daytime fatigue (p = 0.08) in the BUD group compared with the placebo group. The sleep measures showed statistically significant improvement in total sleep measures score (p = 0.04), "sleep compared with absolute" (p = 0.01), and "refreshing and restorative" sleep (p = 0.04) in the active group. Nasal corticosteroid BUD is effective in reducing nasal congestion, daytime Somnolence, and daytime fatigue, and improving sleep quality in PAR.
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efficacy of the topical nasal steroid budesonide on improving sleep and daytime Somnolence in patients with perennial allergic rhinitis
Allergy, 2003Co-Authors: Kathleen Hughes, Erik Lehman, F Gurevich, Casey Glass, L H Fisher, M Ripchinski, T E Weaver, Timothy J CraigAbstract:Background: Improving quality of life is considered to be a major endpoint and motivation for clinical intervention in patients with perennial allergic rhinitis (PAR). In addition to classical symptoms of congestion, pruritus, and rhinorrhea, patients will often complain of not being able to sleep well at night and of feeling fatigued during the day. Like sleep apnea, PAR has also been shown to cause sleep disturbance and consequently worsen daytime fatigue and Somnolence. Hypothesis: It is proposed that by decreasing nasal obstruction due to allergic rhinitis by treating with the topical steroid budesonide, symptoms of daytime fatigue and Somnolence can be improved. Methods: Twenty-two subjects were enrolled in a double-blind, placebo-controlled, crossover study using Baalam's design. Patients were treated with either budesonide 128 μg/day or placebo. Subjective data include the Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Rhino-conjunctivitis Quality of Life Questionnaire, and a daily diary recording nasal symptoms, sleep problems, and daytime fatigue. Results: The results illustrated that the topical nasal corticosteroid significantly improved daytime fatigue (P = 0.03), Somnolence (P = 0.02), and quality of sleep (P = 0.05) compared to placebo in patients suffering from PAR. Summary: Budesonide is able to improve congestion, sleep, and daytime Somnolence.
Vernon M Chinchilli - One of the best experts on this subject based on the ideXlab platform.
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the effect of topical nasal fluticasone on objective sleep testing and the symptoms of rhinitis sleep and daytime Somnolence in perennial allergic rhinitis
Allergy and Asthma Proceedings, 2003Co-Authors: Timothy J Craig, Erik Lehman, Sujani Kakumanu, Cathy Mende, Kathleen Hughes, Vernon M ChinchilliAbstract:: Recent data suggested that daytime Somnolence in patients with allergic rhinitis was secondary to disrupted sleep caused by nasal congestion. Medications, which decreased congestion, would be expected to improve sleep and daytime Somnolence. Previously, we showed that nasal steroids improved all three symptoms. Presently, we have not performed objective sleep testing to determine if there is a correlation between subjective improvement of congestion, sleep, and daytime Somnolence. The objective of this 8-week, double-blind, placebo-controlled study was to determine if topical nasal fluticasone is effective at decreasing subjective congestion and daytime Somnolence and improving sleep and if this improvement correlated with a change in overnight sleep testing (polysomnography). We recruited 32 subjects with perennial allergic rhinitis and randomized them in a double-blinded, cross-over fashion, to receive placebo or fluticasone (50 micrograms a spray), 2 sprays each side everyday, using Balaam's design. Questionnaires, quality of life instruments, daily diary, Epworth Sleepiness Scale, and an overnight sleep test with polysomnograms were used as tools. The last 2 weeks of each 4-week treatment period were summarized, scored, and compared by PROC MIXED in SAS. Correlations between arousals on sleep tests and subjective tests were performed. Fluticasone improved subjective sleep when compared with placebo (p = 0.04); however, there was no difference in the apnea/hypopnea index in those that were treated. Daytime sleepiness and fatigue were decreased by > 10% in the treated group; however, this was not statistically significant. However, fluticasone used at approved doses improves subjective sleep in patients with perennial allergic rhinitis without a change in the apnea/hypopnea index.
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effect of topical nasal azelastine on the symptoms of rhinitis sleep and daytime Somnolence in perennial allergic rhinitis
Annals of Allergy Asthma & Immunology, 2000Co-Authors: Stanley Golden, S Teets, Erik Lehman, Elizabeth A Mauger, Vernon M Chinchilli, Joshua M Berlin, Sujani Kakumanu, Timothy Lucus, Timothy J CraigAbstract:Background Recent data suggested that daytime Somnolence in patients with allergic rhinitis was secondary to disrupted sleep caused by nasal congestion. Medications, which decreased congestion, would be expected to improve sleep and daytime Somnolence. Previously, we demonstrated that nasal steroids improved all three symptoms. The effect of topical nasal antihistamines on these symptoms has yet to be studied. Objective The objective of this 8-week, double-blind, placebo-controlled study was to determine whether topical nasal azelastine was effective at decreasing congestion, daytime Somnolence, and improving sleep. Methods We recruited 24 subjects with perennial allergic rhinitis and randomized them in a double-blinded, crossover fashion, to receive placebo or azelastine two sprays BID, using Balaam's design. Questionnaires, daily diary, and Epworth Sleepiness Scale were used as tools. The last 2 weeks of each 4-week treatment period were summarized, scored, and compared by PROC MIXED in SAS. Results The analysis of the Rhinitis Severity Score showed significant improvement only of rhinorrhea in the azelastine group ( P = .03). The symptom severity of nasal congestion and daytime Somnolence was not significantly different between placebo and azelastine. Subjects considered azelastine effective at improving their sleep ( P = .04), but daytime Somnolence ( P = .06) and congestion ( P = .09) were not statistically improved. Conclusion Azelastine is effective in reducing rhinorrhea and improving sleep quality. We were unable to demonstrate that azelastine can significantly reduce the severity of congestion or daytime Somnolence.
