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Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation

NCT04992676 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2024-07-17

No results posted yet for this study

Summary

The purpose of this research is to determine how frequently sleep disorders such as sleep disordered breathing and insomnia occur in patients with coronary artery disease enrolled in cardiac rehabilitation. By reviewing results of a variety of tests, we also hope to learn more about the cardiovascular effects on people who may have these conditions.

Conditions

Interventions

DIAGNOSTIC_TEST

Polysomnograpy

Home polysomnography will be conducted using the scalable, modular Embletta system. Trained staff will instrument the participants in the evening and perform biocalibration to ensure optimal data quality

DIAGNOSTIC_TEST

actigraphy

A water resistant accelerometer with light sensor and event marker will be worn on the nondominant wrist for approximately 7 days. Activity counts from the device will be analyzed by proprietary software algorithms for determination of the following: sleep onset, sleep offset, total sleep time, total wake time, and sleep efficiency.16 Daytime sleep periods will be also scored to determine frequency and duration of naps. Daily data will be averaged across the 7-day period, as well as separately for weekdays and weekend, to compute measures of habitual sleep patterns.

Sponsors & Collaborators

  • Sleep Number, Inc.

    collaborator UNKNOWN

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Amanda R Bonikowske, PhD · Mayo Clinic

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-19
Primary Completion
2024-05-02
Completion
2024-05-02

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04992676 on ClinicalTrials.gov