Sleep ApneaPOLLARNCT03776773
Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study
A study testing Pollution exposure in people with Sleep Apnea and Allergic Rhinitis, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Allergic Rhinitis, Allergic Asthma
- What is being tested?
- Pollution exposure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2019to 25 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Conditions
- Sleep Apnea, Allergic Rhinitis, Allergic Asthma, Pollution Exposure, Pollution Related Respiratory Disorder
- Being tested
- Pollution exposure
- Medical subject headings
- Sleep Apnea Syndromes, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pollution exposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| patients AR (+) and sleep apnea (+) | Active comparator | Patients with AR and obstructive sleep apnea (OSA) will have sleep and pollution exposure recordings Receives: Other: Pollution exposure |
| AR (-) and sleep apnea (+) | Active comparator | Patients without allergic rhinitis (+ sleep apnea) will have sleep and pollution exposure recordings Receives: Other: Pollution exposure |
| AR (+) and sleep apnea (-) | Active comparator | Patients with allergic rhinitis but no sleep apnea will have sleep and pollution exposure recordings Receives: Other: Pollution exposure |
| AR (-) and sleep apnea (-) | Sham comparator | Volunteers without allergic rhinitis and no sleep apnea will have sleep and pollution exposure recordings Receives: Other: Pollution exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of pollution on sleep
Change in AHI according to the level of pollution particle matters and volatile organic compounds (VOCs)
Measured: 6 days
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start8 Apr 2019
- Primary completion25 Jan 2020
- Study completion25 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776773
- Sponsor's protocol ID
- 38RC18.264
- Acronym
- POLLAR
- Status last verified
- Mar 2020
- First submitted
- 13 Dec 2018
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study
- ClinicalTrials.gov ID
- NCT03776773
- Acronym / sponsor ID
- POLLAR / 38RC18.264
- Conditions
- Sleep Apnea, Allergic Rhinitis, Allergic Asthma, Pollution Exposure, Pollution Related Respiratory Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 25 Jan 2020 (actual)
- Study completion
- 25 Jan 2020 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| patients AR (+) and sleep apnea (+) | Active comparator | Other: Pollution exposurePatients with AR and obstructive sleep apnea (OSA) will have sleep and pollution exposure recordings |
| AR (-) and sleep apnea (+) | Active comparator | Other: Pollution exposurePatients without allergic rhinitis (+ sleep apnea) will have sleep and pollution exposure recordings |
| AR (+) and sleep apnea (-) | Active comparator | Other: Pollution exposurePatients with allergic rhinitis but no sleep apnea will have sleep and pollution exposure recordings |
| AR (-) and sleep apnea (-) | Sham comparator | Other: Pollution exposureVolunteers without allergic rhinitis and no sleep apnea will have sleep and pollution exposure recordings |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pollution exposurePollution 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. | Other | AR (+) and sleep apnea (-), AR (-) and sleep apnea (+), AR (-) and sleep apnea (-), patients AR (+) and sleep apnea (+) |
Primary outcome
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)
3 secondary outcomes
The impact of pollution and pollens on sleep quality in patients with AR.
Time frame: 6 days
The impact of pollution on life quality
Time frame: 6 days
To analyze variations in medications and impact on sleep during the pollen season and outside the pollen season.
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis PEPIN principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pollution exposure in people with Sleep Apnea and Allergic Rhinitis, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of pollution on sleep (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.