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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00808574
Other study ID # HSC-MS-08-0346
Secondary ID
Status Completed
Phase Phase 0
First received December 12, 2008
Last updated December 12, 2008
Start date July 2008
Est. completion date October 2008

Study information

Verified date December 2008
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The current study was a pilot, double blind, randomized controlled trial to (1) evaluate the feasibility of an online obstructive sleep apnea (OSA) screening intervention, (2) estimate effect size for planning of future studies, and (3) test the hypothesis that the intervention, compared to a control condition, would lead more individuals to discuss OSA with their healthcare provider.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Member of SparkPeople.com community and logged on within previous month

- Live in the US

Exclusion Criteria:

- Prior diagnosis of OSA

- Prior discussions with healthcare provider about OSA

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Screening


Intervention

Behavioral:
Obstructive sleep apnea screening intervention
Brief, theory-based, online assessment of OSA risk followed by risk-tailed OSA presentation.

Locations

Country Name City State
United States University of Texas Medical School, Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Online questionnaire asking whether subject has discussed OSA with healthcare provider since enrolling in study 12 weeks No
Secondary Online questionnaire asking whether subject has plans to discuss OSA with healthcare provider, if not done already 12 weeks No
Secondary Online questionnaire asking whether subject has undergone testing and treatment for OSA since enrolling in study 12 weeks No
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