Obstructive Sleep ApneaEarly Phase 1NCT00808574
Screening for Obstructive Sleep Apnea Among Members of an Internet Weight Loss Community
A Early Phase 1 study testing Obstructive sleep apnea screening intervention in people with Obstructive Sleep Apnea, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Obstructive sleep apnea screening intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Oct 2008
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Member of SparkPeople.com community and logged on within previous month
- Live in the US
Who cannot join
- Prior diagnosis of OSA
- Prior discussions with healthcare provider about OSA
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical School, Houston
Houston, Texas, 77030
About this study
Official title: Effect of a Web-Based Presentation on Communication With Healthcare Providers
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Obstructive sleep apnea screening intervention
- Keywords
- Obstructive sleep apnea, Internet, Screening, Health belief model
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstructive sleep apnea screening interventionBehavioural
Brief, theory-based, online assessment of OSA risk followed by risk-tailed OSA presentation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Brief, theory-based, online assessment of OSA risk followed by risk-tailed OSA presentation. Receives: Behavioral: Obstructive sleep apnea screening intervention |
| Control | No intervention | No risk assessment or presentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Online questionnaire asking whether subject has discussed OSA with healthcare provider since enrolling in study
Measured: 12 weeks
Secondary outcomes (2)
Online questionnaire asking whether subject has plans to discuss OSA with healthcare provider, if not done already
Measured: 12 weeks
Online questionnaire asking whether subject has undergone testing and treatment for OSA since enrolling in study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Kevin O Hwang, MD, MPH, Principal investigator, University of Texas Medical School, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808574
- Sponsor's protocol ID
- HSC-MS-08-0346
- Status last verified
- Dec 2008
- First submitted
- 12 Dec 2008
- Last updated
- 16 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Web-Based Presentation on Communication With Healthcare Providers
- ClinicalTrials.gov ID
- NCT00808574
- Acronym / sponsor ID
- HSC-MS-08-0346
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Internet, Screening, Health belief model
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Obstructive sleep apnea screening interventionBrief, theory-based, online assessment of OSA risk followed by risk-tailed OSA presentation. |
| Control | No intervention | –No risk assessment or presentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Member of SparkPeople.com community and logged on within previous month
- Live in the US
Key exclusion criteria (2 listed)
- Prior diagnosis of OSA
- Prior discussions with healthcare provider about OSA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstructive sleep apnea screening interventionBrief, theory-based, online assessment of OSA risk followed by risk-tailed OSA presentation. | Behavioural | Intervention |
Primary outcome
Online questionnaire asking whether subject has discussed OSA with healthcare provider since enrolling in study
Time frame: 12 weeks
2 secondary outcomes
Online questionnaire asking whether subject has plans to discuss OSA with healthcare provider, if not done already
Time frame: 12 weeks
Online questionnaire asking whether subject has undergone testing and treatment for OSA since enrolling in study
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin O Hwang, MD, MPH principal investigator
University of Texas Medical School, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Obstructive sleep apnea screening intervention in people with Obstructive Sleep Apnea, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Online questionnaire asking whether subject has discussed OSA with healthcare provider since enrolling in study (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2008.