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

NCT ID: NCT03776773

Last Updated: 2020-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-08

Study Completion Date

2020-01-25

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

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patients AR (+) and sleep apnea (+)

Patients with AR and obstructive sleep apnea (OSA) will have sleep and pollution exposure recordings

Group Type ACTIVE_COMPARATOR

Pollution exposure

Intervention Type OTHER

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.

AR (-) and sleep apnea (+)

Patients without allergic rhinitis (+ sleep apnea) will have sleep and pollution exposure recordings

Group Type ACTIVE_COMPARATOR

Pollution exposure

Intervention Type OTHER

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.

AR (+) and sleep apnea (-)

Patients with allergic rhinitis but no sleep apnea will have sleep and pollution exposure recordings

Group Type ACTIVE_COMPARATOR

Pollution exposure

Intervention Type OTHER

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.

AR (-) and sleep apnea (-)

Volunteers without allergic rhinitis and no sleep apnea will have sleep and pollution exposure recordings

Group Type SHAM_COMPARATOR

Pollution exposure

Intervention Type OTHER

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.

Interventions

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Pollution exposure

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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Louis PEPIN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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CHU Grenoble

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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38RC18.264

Identifier Type: -

Identifier Source: org_study_id

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