Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01261390 · ClinicalTrials.gov registry record · NA
Sleep Apnea Intervention for Cardiovascular Disease Reduction
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 169
- Enrollment target
NCT01261390 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 169 participants.
The verdict
NCT01261390, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 169 participants
- Enrollment target
Study Summary
Moderate to severe sleep apnea (a high number of breathing pauses on a sleep study) is a common health problem that is often associated with loud snoring and sleepiness.The medical term for this problem is obstructive sleep apnea (OSA). People with OSA often have an increased risk for developing heart disease or may already have a diagnosis of heart disease. A clinical research study is being conducted at Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC) to compare the effects of continuous positive airway pressure (CPAP) to conservative medical therapy with participation in one of four groups: 1. Active-PAP Therapy Group (Active-Beh or Active+Beh): Will receive standard medical treatment for sleep apnea with active-PAP. Participants will be randomized to either: 1. Active-Pap with respiratory therapist visits only 2. Active-Pap with respiratory therapist visits and cognitive behavioral therapist visits. 2. Alternative PAP Group (Sham): Will receive lower air delivery level than active-PAP therapy group. Will also have meetings with respiratory therapist. 3. Conservative Medical Therapy Group (CMT)\*: Will receive a free supply of nasal strips for the duration of their treatment period (either 6 months or 12 months) and follow healthy sleep hygiene guidelines for how to change sleep habits to minimize incidences of apneas (breathing disturbances during sleep). Frequent follow-up support with research coordinator. A sleep doctor or cardiologist will have indicated that a potential participant is an appropriate candidate to receive PAP or CMT as acceptable approaches to treat his/her sleep apnea. Participants will be recruited between the ages of 45-75 years who have diagnosed heart disease or between 55-75 years for those who have risk factors for developing heart disease. This is a 6-12 month study\*\* to evaluate alternative ways to address the potential for OSA treatment to reduce heart disease and to identify those fea
Interventions
- BEHAVIORAL Conservative Medical Therapy (CMT)
- DEVICE Sham PAP (Sham)
- DEVICE Active PAP with RT Support (Active-Beh)
- DEVICE Active PAP with Behavioral Modification (Active+Beh)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01261390
The ClinicalTrials.gov registry entry for NCT01261390 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Conservative Medical Therapy (CMT) is the first listed.
NCT01261390 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01261390 about?
NCT01261390 is a clinical study titled "Sleep Apnea Intervention for Cardiovascular Disease Reduction". Moderate to severe sleep apnea (a high number of breathing pauses on a sleep study) is a common health problem that is often associated with loud snoring and sleepiness.The medical term for this problem is obstructive sleep apnea (OSA). People with OSA often have an increased risk for developing hea...
What is the current status of trial NCT01261390?
This trial is currently completed. It is a NA study. The enrollment target is 169 participants. The study started on 2011-03. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01261390?
The interventions under investigation include: Conservative Medical Therapy (CMT) (BEHAVIORAL), Sham PAP (Sham) (DEVICE), Active PAP with RT Support (Active-Beh) (DEVICE), Active PAP with Behavioral Modification (Active+Beh) (DEVICE).
Who is sponsoring clinical trial NCT01261390?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.