NCT00544752

Brief Summary

The purpose of this study is to test whether different indoor temperature affect the frequency of sleep apnea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 14, 2011

Status Verified

April 1, 2011

Enrollment Period

5.9 years

First QC Date

October 12, 2007

Last Update Submit

April 13, 2011

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea syndromes, ambient indoor temperature

Outcome Measures

Primary Outcomes (1)

  • Apnea hypopnea index, karolinska sleepiness scale

    one night

Secondary Outcomes (1)

  • Sleep stages, sleep efficiency

    One night

Study Arms (3)

16

EXPERIMENTAL

indoor temperature of 16 degrees celcius

Other: 16

20

EXPERIMENTAL

indoor temperature 20 degrees celcius

Other: indoor temperature of 20 degrees celcius

24

EXPERIMENTAL

indoor temperature of 24 degrees celcius

Other: indoor temperature of 24 degrees celcius

Interventions

16OTHER

indoor temperature of 16 degrees celcius

16
indoor temperature of 20 degrees celciusOTHER

indoor temperature of 20 degrees celcius

20
indoor temperature of 24 degrees celciusOTHER

indoor temperature of 24 degrees celcius

24

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Obstructive sleep apnea

You may not qualify if:

  • Central sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of respiratory medicine

Umeå, SE 901 85, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 22467989DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Karl A Franklin, MD, PhD

    Dept Respiratory Medicine, University Hospital, Umeå

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 16, 2007

Study Start

January 1, 2005

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

April 14, 2011

Record last verified: 2011-04

Locations

SE(1)