Clinical Trials Logo
  1. Home
  2. Obstructive Sleep Apnea
  3. NCT02005445
  4. Details
NCT02005445 Clinical Trial

Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

Obstructive Sleep Apnea Clinical Trial

Official title:
Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02005445
Other study ID # F1351-P
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 1, 2014
Est. completion date June 29, 2018

Study information
Verified date June 2019
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized clinical trial in U.S. Veterans to evaluate the impact of treatment for obstructive sleep apnea (OSA) on the effectiveness of cardiac rehabilitation, including impact on exercise capacity, disability, and quality of life.

Description:

Obstructive sleep apnea (OSA) is a highly prevalent condition in patients with coronary heart disease and is associated with impaired exercise performance, functional limitation and reduced health-related quality of life. The investigators hypothesize that identification and treatment of OSA in patients undergoing cardiac rehabilitation will improve the response to rehabilitation. The proposed study will test this hypothesis using a parallel group, randomized, clinical trial comparing OSA treatment with continuous positive airway pressure (CPAP) to an educational control group in patients undergoing cardiac rehabilitation who screen positive for previously undiagnosed OSA.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date June 29, 2018
Est. primary completion date December 29, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Veterans referred for cardiac rehabilitation at the VA Boston Healthcare System.

- Moderate to severe OSA (AHI >15) on home sleep testing.

Exclusion Criteria:

- Dangerous levels of sleepiness (Epworth Sleepiness Scale score >16 or a report of falling asleep at the wheel of a car within the past 2 years).

- Physical limitation precluding exercise testing.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CPAP
Continuous positive airway pressure
Behavioral:
• HLSE
Healthy living and sleep education

Locations
Country Name City State
United States VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary WHO Disability Assessment Scale 2 Scores Functional status as measured by the World Health Organization Disability Assessment Scale 2.0. Score range 0-48 (higher scores indicate more disability). 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05857384 - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs Phase 1
Recruiting NCT04547543 - Follow-up of Apneic Patients by Visio-consultation N/A
Recruiting NCT05371509 - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study N/A
Completed NCT02515357 - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea N/A
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Active, not recruiting NCT03189173 - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea Phase 2
Completed NCT04084899 - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed NCT03032029 - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting NCT04028011 - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting NCT06047353 - Community Health Advocates for Motivating PAP Use in Our Neighborhoods. N/A
Completed NCT05253963 - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea N/A
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed NCT03589417 - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting NCT04335994 - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing N/A
Withdrawn NCT04063436 - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea N/A
Recruiting NCT05385302 - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting NCT04572269 - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting NCT06467682 - 12-week Tele-exercise Program in Patients With OSA N/A
Withdrawn NCT04011358 - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study N/A