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

Primary Purpose

Sleep Apnea, Allergic Rhinitis, Allergic Asthma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pollution exposure
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep Apnea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU Grenoble

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

patients AR (+) and sleep apnea (+)

AR (-) and sleep apnea (+)

AR (+) and sleep apnea (-)

AR (-) and sleep apnea (-)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
December 13, 2018
Last Updated
March 12, 2020
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03776773
Brief Title
Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study
Acronym
POLLAR
Official Title
Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
January 25, 2020 (Actual)
Study Completion Date
January 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Allergic Rhinitis, Allergic Asthma, Pollution Exposure, Pollution Related Respiratory Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients AR (+) and sleep apnea (+)
Arm Type
Active Comparator
Arm Description
Patients with AR and obstructive sleep apnea (OSA) will have sleep and pollution exposure recordings
Arm Title
AR (-) and sleep apnea (+)
Arm Type
Active Comparator
Arm Description
Patients without allergic rhinitis (+ sleep apnea) will have sleep and pollution exposure recordings
Arm Title
AR (+) and sleep apnea (-)
Arm Type
Active Comparator
Arm Description
Patients with allergic rhinitis but no sleep apnea will have sleep and pollution exposure recordings
Arm Title
AR (-) and sleep apnea (-)
Arm Type
Sham Comparator
Arm Description
Volunteers without allergic rhinitis and no sleep apnea will have sleep and pollution exposure recordings
Intervention Type
Other
Intervention Name(s)
Pollution exposure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Impact of pollution on sleep
Description
Change in AHI according to the level of pollution particle matters and volatile organic compounds (VOCs)
Time Frame
6 days
Secondary Outcome Measure Information:
Title
The impact of pollution and pollens on sleep quality in patients with AR.
Description
Change in Pittsburgh score according to the level of pollution particle matters and volatile organic compounds (VOCs)
Time Frame
6 days
Title
The impact of pollution on life quality
Description
Change in EQ-5D score according to the level of pollution particle matters and volatile organic compounds (VOCs)
Time Frame
6 days
Title
To analyze variations in medications and impact on sleep during the pollen season and outside the pollen season.
Description
Change in number of medications (antiallergics and hypnotics) according to the level of pollution particle matters and volatile organic compounds (VOCs)
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis PEPIN
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Grenoble
City
Grenoble
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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