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

NCT03776773 | Completed

• 1 other identifier: 38RC18.264
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Impact of pollution on sleep

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

  6 days

Secondary Outcomes (3)

• The impact of pollution and pollens on sleep quality in patients with AR.

  6 days

• The impact of pollution on life quality

  6 days

• To analyze variations in medications and impact on sleep during the pollen season and outside the pollen season.

  6 days

Study Arms (4)

patients AR (+) and sleep apnea (+)

ACTIVE COMPARATOR

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

Other: Pollution exposure

AR (-) and sleep apnea (+)

ACTIVE COMPARATOR

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

Other: Pollution exposure

AR (+) and sleep apnea (-)

ACTIVE COMPARATOR

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

Other: Pollution exposure

AR (-) and sleep apnea (-)

SHAM COMPARATOR

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

Other: Pollution exposure

Interventions

Pollution exposure 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 (-); AR (-) and sleep apnea (+); AR (-) and sleep apnea (-); patients AR (+) and sleep apnea (+)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble

Grenoble, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Rhinitis; Nose Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jean-Louis PEPIN

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 17, 2018
• Study Start: April 8, 2019
• Primary Completion: January 25, 2020
• Study Completion: January 25, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

FR (1)