NCT00808574

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2008

Shorter than P25 for early_phase_1

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

July 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
Last Updated

December 16, 2008

Status Verified

December 1, 2008

Enrollment Period

3 months

First QC Date

December 12, 2008

Last Update Submit

December 12, 2008

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apneaInternetScreeningHealth belief model

Outcome Measures

Primary Outcomes (1)

  • Online questionnaire asking whether subject has discussed OSA with healthcare provider since enrolling in study

    12 weeks

Secondary Outcomes (2)

  • Online questionnaire asking whether subject has plans to discuss OSA with healthcare provider, if not done already

    12 weeks

  • Online questionnaire asking whether subject has undergone testing and treatment for OSA since enrolling in study

    12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Brief, theory-based, online assessment of OSA risk followed by risk-tailed OSA presentation.

Behavioral: Obstructive sleep apnea screening intervention

Control

NO INTERVENTION

No risk assessment or presentation

Interventions

Obstructive sleep apnea screening interventionBEHAVIORAL

Brief, theory-based, online assessment of OSA risk followed by risk-tailed OSA presentation.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Member of SparkPeople.com community and logged on within previous month
  • Live in the US

You may not qualify if:

  • Prior diagnosis of OSA
  • Prior discussions with healthcare provider about OSA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical School, Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Kevin O Hwang, MD, MPH

    University of Texas Medical School, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2008

First Posted

December 16, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 16, 2008

Record last verified: 2008-12

Locations

US(1)