Clinical trial NCT03776773: Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study
Official title: Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Allergic Rhinitis
Allergic Asthma
Pollution Exposure
Pollution Related Respiratory Disorder
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of pollution on sleep
timeFrame: 6 days
Secondary outcomes:
measure: The impact of pollution and pollens on sleep quality in patients with AR.
timeFrame: 6 days
measure: The impact of pollution on life quality
timeFrame: 6 days
measure: To analyze variations in medications and impact on sleep during the pollen season and outside the pollen season.
timeFrame: 6 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis PEPIN
role: PRINCIPAL_INVESTIGATOR
References: