Expired Study
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Houston, Texas 77030


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

HSC-MS-08-0346


NCT ID:

NCT00808574


Secondary ID:


Study Acronym:


Brief Title:

Screening for Obstructive Sleep Apnea Among Members of an Internet Weight Loss Community


Official Title:

Effect of a Web-Based Presentation on Communication With Healthcare Providers


Overall Status:

Completed


Study Phase:

Phase 0


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The University of Texas Health Science Center, Houston


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

168


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kevin O Hwang, MD, MPH
Principal Investigator
University of Texas Medical School, Houston

Study Dates

Start Date:July 2008
Completion Date:October 2008
Completion Type:Actual
Primary Completion Date:October 2008
Primary Completion Type:Actual
Verification Date:December 2008
Last Changed Date:December 12, 2008
First Received Date:December 12, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Online questionnaire asking whether subject has undergone testing and treatment for OSA since enrolling in study
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Online questionnaire asking whether subject has plans to discuss OSA with healthcare provider, if not done already
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Online questionnaire asking whether subject has discussed OSA with healthcare provider since enrolling in study
Time Frame:12 weeks
Safety Issues:False

Study Interventions

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

Study Arms

Study Arm Type:No Intervention
Arm Name:Control
Description:No risk assessment or presentation
Study Arm Type:Experimental
Arm Name:Intervention
Description:Brief, theory-based, online assessment of OSA risk followed by risk-tailed OSA presentation.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The University of Texas Health Science Center, Houston

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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