Coronary Artery DiseaseNCT04992676
Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation
An observational study of Coronary Artery Disease and Sleep Disorder; Breathing-Related, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Disease, Sleep Disorder; Breathing-Related, Sleep Disorder; Insomnia Type
- What is being tested?
- Polysomnograpy and actigraphy
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 2 May 2024
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: coronary artery disease patients participating in cardiac rehab
Who may be able to join
- Patients will be >18 years old
- Referred to CR following admitted to the hospital with a documented diagnosis of acute coronary syndrome
- Referred to CR following admission to the hospital with a documented diagnosis of ST- elevation myocardial infarction (STEMI),
- Referred to CR following admission to the hospital with a documented diagnosis of non- STEMI
- Referred to CR following admission to the hospital with a documented diagnosis of unstable angina
- Referred to CR following admission to the hospital with a documented diagnosis of post coronary artery bypass surgery
- Referred to CR following admission to the hospital after percutaneous coronary intervention (with or without stent placement).
Who cannot join
- heart failure with reduced ejection fraction
- peripheral artery disease
- valve or pericardial surgery
- heart transplantation
- patients unable to provide informed consent
- patients unable to speak and read English
Show all 9Show fewer
- night shift workers
- pregnant women
- those who will only attend full home-based CR.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation: Prevalence and Impact on Cardiovascular Risk Profile
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.
Read the detailed description
Patients referred to the Mayo Clinic Rochester CR and meeting eligibility criteria (see Subjects section below) will be recruited and consented. Prior to beginning CR, enrolled patients will undergo baseline sleep and CV assessment at the Clinical Research and Trials Unit (CRTU). Home-based sleep monitoring will take place. Patients will also complete additional cardiometabolic and behavioral evaluation as part of the standard CR clinical care. Following completion of the 12-week CR program, a post-CR assessment may be conducted, including the same set of tests/procedures. All patients will be followed up for at least 6-months following enrollment to monitor cardiac recurrence, hospitalization and death.
- Being tested
- Polysomnograpy, actigraphy
- Medical subject headings
- Coronary Artery Disease, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnograpyDiagnostic test
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
actigraphyDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the prevalence of comorbid sleep disordered breathing and insomnia in post-MI patients enrolled in cardiac rehab.
Comorbid SDB and insomnia will be highly prevalent (>30%) in this population. Measured by home, overnight polysomnography
Measured: 6 months
The combination of both sleep disorders will be associated with more detrimental CV risk markers (cardiorespiratory fitness) than either sleep disorder alone.
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
Measured: 6 months
The combination of both sleep disorders will be associated with more detrimental CV risk markers (blood pressure) than either sleep disorder alone
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
Measured: 6 months
The combination of both sleep disorders will be associated with more detrimental CV risk markers (lipids) than either sleep disorder alone
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
Measured: 6 months
The combination of both sleep disorders will be associated with more detrimental CV risk markers (depression) than either sleep disorder alone
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without using the PHQ-9.
Measured: 6 months
The combination of both sleep disorders will be associated with lower adherence to CR - number of attended sessions
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to CR attendance than those without
Measured: 6 months
The combination of both sleep disorders will be associated with lower adherence to CR - adherence to pharmacotherapy
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to prescribed medications than those without
Measured: 6 months
The combination of both sleep disorders will be associated with lower adherence to CR - exercise
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to the exercise prescription than those without
Measured: 6 months
The combination of both sleep disorders will be associated with lower adherence to CR - dietary prescription
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to dietary recommendations than those without
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start19 Aug 2021
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Sleep Number, Inc.
- Responsible party
- Principal investigator, Amanda R. Bonikowske, Mayo Clinic
- Investigators
- Amanda R Bonikowske, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992676
- Sponsor's protocol ID
- 21-002556
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2021
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation: Prevalence and Impact on Cardiovascular Risk Profile
- ClinicalTrials.gov ID
- NCT04992676
- Acronym / sponsor ID
- 21-002556
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Sleep Number, Inc.
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 5 Aug 2021 (actual)
- 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 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.
Detailed description
Patients referred to the Mayo Clinic Rochester CR and meeting eligibility criteria (see Subjects section below) will be recruited and consented. Prior to beginning CR, enrolled patients will undergo baseline sleep and CV assessment at the Clinical Research and Trials Unit (CRTU). Home-based sleep monitoring will take place. Patients will also complete additional cardiometabolic and behavioral evaluation as part of the standard CR clinical care. Following completion of the 12-week CR program, a post-CR assessment may be conducted, including the same set of tests/procedures. All patients will be followed up for at least 6-months following enrollment to monitor cardiac recurrence, hospitalization and death.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- coronary artery disease patients participating in cardiac rehab
Key inclusion criteria (7 listed)
- Patients will be >18 years old
- Referred to CR following admitted to the hospital with a documented diagnosis of acute coronary syndrome
- Referred to CR following admission to the hospital with a documented diagnosis of ST- elevation myocardial infarction (STEMI),
- Referred to CR following admission to the hospital with a documented diagnosis of non- STEMI
- Referred to CR following admission to the hospital with a documented diagnosis of unstable angina
Key exclusion criteria (9 listed)
- heart failure with reduced ejection fraction
- peripheral artery disease
- valve or pericardial surgery
- heart transplantation
- patients unable to provide informed consent
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 |
|---|---|---|
| PolysomnograpyHome 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 | – |
| actigraphyA 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. | Diagnostic test | – |
Primary outcome
To examine the prevalence of comorbid sleep disordered breathing and insomnia in post-MI patients enrolled in cardiac rehab.
Time frame: 6 months
Comorbid SDB and insomnia will be highly prevalent (>30%) in this population. Measured by home, overnight polysomnography
The combination of both sleep disorders will be associated with more detrimental CV risk markers (cardiorespiratory fitness) than either sleep disorder alone.
Time frame: 6 months
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
The combination of both sleep disorders will be associated with more detrimental CV risk markers (blood pressure) than either sleep disorder alone
Time frame: 6 months
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
The combination of both sleep disorders will be associated with more detrimental CV risk markers (lipids) than either sleep disorder alone
Time frame: 6 months
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
The combination of both sleep disorders will be associated with more detrimental CV risk markers (depression) than either sleep disorder alone
Time frame: 6 months
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without using the PHQ-9.
The combination of both sleep disorders will be associated with lower adherence to CR - number of attended sessions
Time frame: 6 months
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to CR attendance than those without
The combination of both sleep disorders will be associated with lower adherence to CR - adherence to pharmacotherapy
Time frame: 6 months
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to prescribed medications than those without
The combination of both sleep disorders will be associated with lower adherence to CR - exercise
Time frame: 6 months
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to the exercise prescription than those without
The combination of both sleep disorders will be associated with lower adherence to CR - dietary prescription
Time frame: 6 months
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to dietary recommendations than those without
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 17 Jul 2024.
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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.
Amanda R Bonikowske, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Sleep Disorder; Breathing-Related, run by Mayo Clinic 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 7 inclusion and 9 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 17 Jul 2024. 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.
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?
To examine the prevalence of comorbid sleep disordered breathing and insomnia in post-MI patients enrolled in cardiac rehab. (time frame: 6 months). The study lists 9 primary outcomes in all. 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 17 Jul 2024.