Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study

Study Overview
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Brief Summary
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It has been demonstrated that allergic rhinitis (AR) reduces sleep quality by some components such as nasal obstruction. Pollution and allergen exposure worsening AR, sleep quality is deteriorated. Sleep is associated to physical and mental health, alterations in sleep could explain the link between AR and work productivity diminution, impairment in daily activities or emotional problems. However, interactions between air pollution, sleep and allergic diseases are insufficiently understood. The main objective of this study is to determine the impact of pollution and pollens on sleep parameters.

Detailed Description
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Over 150 million people have allergic rhinitis (AR) in Europe and around 30% have uncontrolled AR during allergen exposure. It has been demonstrated that AR reduces sleep quality by some components such as nasal obstruction. Pollution and allergen exposure worsening AR, sleep quality is deteriorated. Sleep is associated to physical and mental health, alterations in sleep could explain the link between AR and work productivity diminution, impairment in daily activities or emotional problems. However, interactions between air pollution, sleep and allergic diseases are insufficiently understood. Moreover, the prevalence of OSA in patients with AR is higher than in subjects without AR. Nasal obstruction could explain the increased risk of OSA. This prospective, open study will compare sleep quality in 2 different groups: AR patients and patients without AR during the pollen season and outside the pollen season.The main objective is to determine the impact of pollution and pollens on sleep parameters for subjects with AR

Official Title
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Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study

Conditions
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Sleep Apnea, Allergic Rhinitis, Allergic Asthma, Pollution Exposure, Pollution Related Respiratory Disorder

Intervention / Treatment
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* Other: Pollution exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years Be able to use an application on a personal smartphone Patient non treated for OSA Be legally able to give consent Person affiliated to social security Exclusion Criteria: - Being unable to understand, follow objectives and methods due to cognition or language problems Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, open study comparing sleep quality in 2 different groups: AR patients and patients without AR during the pollen season and outside the pollen season.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients AR (+) and sleep apnea (+)<br>Patients with AR and obstructive sleep apnea (OSA) will have sleep and pollution exposure recordings | Other: Pollution exposure<br>* Pollution exposure and sleep data will be recorded by pollution sensor and polysomnography respectively. In order to compare the variations according to the pollinisation season and the allergic rhinitis status of the patients.<br>|
| Active Comparator: AR (-) and sleep apnea (+)<br>Patients without allergic rhinitis (+ sleep apnea) will have sleep and pollution exposure recordings | Other: Pollution exposure<br>* Pollution exposure and sleep data will be recorded by pollution sensor and polysomnography respectively. In order to compare the variations according to the pollinisation season and the allergic rhinitis status of the patients.<br>|
| Active Comparator: AR (+) and sleep apnea (-)<br>Patients with allergic rhinitis but no sleep apnea will have sleep and pollution exposure recordings | Other: Pollution exposure<br>* Pollution exposure and sleep data will be recorded by pollution sensor and polysomnography respectively. In order to compare the variations according to the pollinisation season and the allergic rhinitis status of the patients.<br>|
| Sham Comparator: AR (-) and sleep apnea (-)<br>Volunteers without allergic rhinitis and no sleep apnea will have sleep and pollution exposure recordings | Other: Pollution exposure<br>* Pollution exposure and sleep data will be recorded by pollution sensor and polysomnography respectively. In order to compare the variations according to the pollinisation season and the allergic rhinitis status of the patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of pollution on sleep | Change in AHI according to the level of pollution particle matters and volatile organic compounds (VOCs) | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of pollution and pollens on sleep quality in patients with AR. | Change in Pittsburgh score according to the level of pollution particle matters and volatile organic compounds (VOCs) | 6 days | 
| The impact of pollution on life quality | Change in EQ-5D score according to the level of pollution particle matters and volatile organic compounds (VOCs) | 6 days | 
| To analyze variations in medications and impact on sleep during the pollen season and outside the pollen season. | Change in number of medications (antiallergics and hypnotics) according to the level of pollution particle matters and volatile organic compounds (VOCs) | 6 days |