Obstructive Sleep ApneaNCT00544752
Indoor Temperature and Sleep Apnea
A study testing 16, indoor temperature of 20 degrees celcius and indoor temperature of 24 degrees celcius in people with Obstructive Sleep Apnea, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of this study is to test whether different indoor temperature affect the frequency of sleep apnea. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- 16, indoor temperature of 20 degrees celcius and indoor temperature of 24 degrees celcius
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2005to Jan 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Obstructive sleep apnea
Who cannot join
- Central sleep apnea
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test whether different indoor temperature affect the frequency of sleep apnea.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- 16, indoor temperature of 20 degrees celcius, indoor temperature of 24 degrees celcius
- Keywords
- sleep apnea syndromes, ambient indoor temperature
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16Other
indoor temperature of 16 degrees celcius
indoor temperature of 20 degrees celciusOther
indoor temperature of 20 degrees celcius
indoor temperature of 24 degrees celciusOther
indoor temperature of 24 degrees celcius
| Study group | Role | What they receive |
|---|---|---|
| 16 | Experimental | indoor temperature of 16 degrees celcius Receives: Other: 16 |
| 20 | Experimental | indoor temperature 20 degrees celcius Receives: Other: indoor temperature of 20 degrees celcius |
| 24 | Experimental | indoor temperature of 24 degrees celcius Receives: Other: indoor temperature of 24 degrees celcius |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea hypopnea index, karolinska sleepiness scale
Measured: one night
Secondary outcomes (1)
Sleep stages, sleep efficiency
Measured: One night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startJan 2005
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Investigators
- Karl A Franklin, MD, PhD, Principal investigator, Dept Respiratory Medicine, University Hospital, Umeå
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544752
- Sponsor's protocol ID
- 03-563
- Status last verified
- Apr 2011
- First submitted
- 12 Oct 2007
- Last updated
- 14 Apr 2011
- Results posted
- No
Publications
Valham F, Sahlin C, Stenlund H, Franklin KA. Ambient temperature and obstructive sleep apnea: effects on sleep, sleep apnea, and morning alertness. Sleep. 2012 Apr 1;35(4):513-7. doi: 10.5665/sleep.1736.
PubMed 22467989
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indoor Temperature and Sleep Apnea
- ClinicalTrials.gov ID
- NCT00544752
- Acronym / sponsor ID
- 03-563
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep apnea syndromes, ambient indoor temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Study start
- Jan 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Oct 2007 (estimated)
- 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.
The purpose of this study is to test whether different indoor temperature affect the frequency of sleep apnea.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 16 | Experimental | Other: 16indoor temperature of 16 degrees celcius |
| 20 | Experimental | Other: indoor temperature of 20 degrees celciusindoor temperature 20 degrees celcius |
| 24 | Experimental | Other: indoor temperature of 24 degrees celciusindoor temperature of 24 degrees celcius |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Obstructive sleep apnea
Key exclusion criteria (1 listed)
- Central sleep apnea
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 |
|---|---|---|
| 16indoor temperature of 16 degrees celcius | Other | 16 |
| indoor temperature of 20 degrees celciusindoor temperature of 20 degrees celcius | Other | 20 |
| indoor temperature of 24 degrees celciusindoor temperature of 24 degrees celcius | Other | 24 |
Primary outcome
Apnea hypopnea index, karolinska sleepiness scale
Time frame: one night
1 secondary outcome
Sleep stages, sleep efficiency
Time frame: One night
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 14 Apr 2011.
- Derived from this study: PubMed 22467989Valham F, Sahlin C, Stenlund H, Franklin KA. Ambient temperature and obstructive sleep apnea: effects on sleep, sleep apnea, and morning alertness. Sleep. 2012 Apr 1;35(4):513-7. doi: 10.5665/sleep.1736.
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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.
Karl A Franklin, MD, PhD principal investigator
Dept Respiratory Medicine, University Hospital, Umeå
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16, indoor temperature of 20 degrees celcius and indoor temperature of 24 degrees celcius in people with Obstructive Sleep Apnea, run by Umeå University at 1 site in Sweden.
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 1 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 14 Apr 2011. 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 Sweden. 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. 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?
Apnea hypopnea index, karolinska sleepiness scale (time frame: one night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00544752, which also lists 1 linked publication.
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 14 Apr 2011.