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

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ClinicalTrials.gov Identifier: NCT03776773
Recruitment Status : Completed
First Posted : December 17, 2018
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sleep Apnea Allergic Rhinitis Allergic Asthma Pollution Exposure Pollution Related Respiratory Disorder Other: Pollution exposure Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study
Actual Study Start Date : April 8, 2019
Actual Primary Completion Date : January 25, 2020
Actual Study Completion Date : January 25, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Impact of pollution on sleep [ Time Frame: 6 days ]
    Change in AHI according to the level of pollution particle matters and volatile organic compounds (VOCs)


Secondary Outcome Measures :
  1. The impact of pollution and pollens on sleep quality in patients with AR. [ Time Frame: 6 days ]
    Change in Pittsburgh score according to the level of pollution particle matters and volatile organic compounds (VOCs)

  2. The impact of pollution on life quality [ Time Frame: 6 days ]
    Change in EQ-5D score according to the level of pollution particle matters and volatile organic compounds (VOCs)

  3. To analyze variations in medications and impact on sleep during the pollen season and outside the pollen season. [ Time Frame: 6 days ]
    Change in number of medications (antiallergics and hypnotics) according to the level of pollution particle matters and volatile organic compounds (VOCs)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776773


Locations
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France
CHU Grenoble
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Jean-Louis PEPIN University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03776773    
Other Study ID Numbers: 38RC18.264
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections
Infections
 Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases