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Completed

NCT Number: NCT03776773

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: POLLAR

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2018
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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