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

Allergic Rhinitis Clinical Trial

— POLLAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776773
• Other study ID #: 38RC18.264
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: January 25, 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 25, 2020
• Est. primary completion date: January 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Rhinitis
• Pollution Exposure
• Pollution Related Respiratory Disorder
• Respiration Disorders
• Respiratory Tract Diseases
• Rhinitis
• Rhinitis, Allergic
• Sleep Apnea

Intervention

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.

Locations

Country	Name	City	State
France	CHU Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of pollution on sleep	Change in AHI according to the level of pollution particle matters and volatile organic compounds (VOCs)	6 days
Secondary	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
Secondary	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
Secondary	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