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

Not Applicable

Completed

• Conditions: Allergic Rhinitis; Pollution Exposure; Sleep Apnea; Allergic Asthma; Pollution Related Respiratory Disorder
• Interventions: Other: Pollution exposure

• Registration Number: NCT03776773
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-17
• Study Start: 2019-04-08
• Primary Completion: 2020-01-25
• Study Completion: 2020-01-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AR (-) and sleep apnea (+)	Pollution exposure	Patients without allergic rhinitis (+ sleep apnea) will have sleep and pollution exposure recordings
patients AR (+) and sleep apnea (+)	Pollution exposure	Patients with AR and obstructive sleep apnea (OSA) will have sleep and pollution exposure recordings
AR (+) and sleep apnea (-)	Pollution exposure	Patients with allergic rhinitis but no sleep apnea will have sleep and pollution exposure recordings
AR (-) and sleep apnea (-)	Pollution exposure	Volunteers without allergic rhinitis and no sleep apnea will have sleep and pollution exposure recordings

Primary Outcome Measures

Name	Time	Method
Impact of pollution on sleep	6 days	Change in AHI according to the level of pollution particle matters and volatile organic compounds (VOCs)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Grenoble; 🇫🇷 Grenoble, France