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Indoor Temperature and Sleep Apnea

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ClinicalTrials.gov Identifier: NCT00544752
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : April 14, 2011
Sponsor:
Collaborator:
Swedish Heart Lung Foundation
Information provided by:
Umeå University

Tracking Information
First Submitted Date  ICMJE October 12, 2007
First Posted Date  ICMJE October 16, 2007
Last Update Posted Date April 14, 2011
Study Start Date  ICMJE January 2005
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2007)
Apnea hypopnea index, karolinska sleepiness scale [ Time Frame: one night ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2007)
Sleep stages, sleep efficiency [ Time Frame: One night ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Indoor Temperature and Sleep Apnea
Official Title  ICMJE Indoor Temperature and Sleep Apnea
Brief Summary The purpose of this study is to test whether different indoor temperature affect the frequency of sleep apnea.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • Other: 16
    indoor temperature of 16 degrees celcius
  • Other: indoor temperature of 20 degrees celcius
    indoor temperature of 20 degrees celcius
  • Other: indoor temperature of 24 degrees celcius
    indoor temperature of 24 degrees celcius
Study Arms  ICMJE
  • Experimental: 16
    indoor temperature of 16 degrees celcius
    Intervention: Other: 16
  • Experimental: 20
    indoor temperature 20 degrees celcius
    Intervention: Other: indoor temperature of 20 degrees celcius
  • Experimental: 24
    indoor temperature of 24 degrees celcius
    Intervention: Other: indoor temperature of 24 degrees celcius
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2011)
40
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2007)
25
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Obstructive sleep apnea

Exclusion Criteria:

  • Central sleep apnea
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00544752
Other Study ID Numbers  ICMJE 03-563
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ass Prof Karl Franklin, Umeå University
Study Sponsor  ICMJE Umeå University
Collaborators  ICMJE Swedish Heart Lung Foundation
Investigators  ICMJE
Principal Investigator: Karl A Franklin, MD, PhD Dept Respiratory Medicine, University Hospital, Umeå
PRS Account Umeå University
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP