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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea; Allergic Rhinitis; Allergic Asthma; Pollution Related Respiratory Disorder; Pollution Exposure
• Intervention / Treatment: Other: Pollution exposure

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • CHU Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: patients AR (+) and sleep apnea (+); Patients with AR and obstructive sleep apnea (OSA) will have sleep and pollution exposure recordings	Other: 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.
ACTIVE_COMPARATOR: AR (-) and sleep apnea (+); Patients without allergic rhinitis (+ sleep apnea) will have sleep and pollution exposure recordings	Other: 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.
ACTIVE_COMPARATOR: AR (+) and sleep apnea (-); Patients with allergic rhinitis but no sleep apnea will have sleep and pollution exposure recordings	Other: 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.
SHAM_COMPARATOR: AR (-) and sleep apnea (-); Volunteers without allergic rhinitis and no sleep apnea will have sleep and pollution exposure recordings	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2019
• Primary Completion (ACTUAL): January 25, 2020
• Study Completion (ACTUAL): January 25, 2020

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (ACTUAL): December 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 38RC18.264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No