Sleep Wake DisordersNCT04506112
Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics
A study testing Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation in people with Sleep Wake Disorders and Sleep Disturbance, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The study aims are to: 1) optimize the Transdiagnostic Sleep and Circadian Intervention (TranS-C) for delivery to Veterans in cardiac rehabilitation, 2) test and refine the adapted TranS-C treatment manual and protocol, and 3) conduct a pilot randomized trial to establish the feasibility, acceptability, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Wake Disorders, Sleep Disturbance, Sleep-Related Impairment
- What is being tested?
- Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2022to 16 Apr 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- Age 18 years or older
- Referred for VAPHS cardiac rehabilitation
- Self-reported sleep disturbance or sleep-related impairment, determined by PROMIS Sleep Disturbance T-score at least 55 (raw score at least 25) or PROMIS Sleep-Related Impairment T-score at least 55 (raw score at least 20)
- English language fluency
- Willing and able to voluntarily participate in a behavioral sleep intervention clinical research study
Show all 9Show fewer
- Willing to permit study personnel access to VA EHR
- Willing to permit study personnel to communicate with routine VA healthcare providers
- Willing and able to participate in outpatient cardiac rehabilitation at VAPHS
Who cannot join
- Moderate to severe cognitive impairment
- Active suicidal ideation, plan, or intent
- Current moderate to severe alcohol or substance use disorder
- Current severe symptoms of depression, anxiety, mania/hypomania, psychosis, or PTSD
- Currently engaged in a non-pharmacological intervention for sleep
- Currently working night shifts
- Currently pregnant and/or breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
The study aims are to: 1) optimize the Transdiagnostic Sleep and Circadian Intervention (TranS-C) for delivery to Veterans in cardiac rehabilitation, 2) test and refine the adapted TranS-C treatment manual and protocol, and 3) conduct a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures.
Read the detailed description
Aim 1 will involve formative work to optimize the TranS-C manual and protocol for delivery in Cardiac Rehabilitation, with input from Veterans and provider stakeholders. Aim 2 will involve a preliminary test and refinement of the adapted TranS-C manual and protocol with a small sample of Veterans who are participating in cardiac rehabilitation and report sleep disturbance and/or sleep-related impairment. Aim 3 will involve a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures. Veterans in cardiac rehabilitation with sleep disturbance and/or sleep-related impairment will be randomized to TranS-C + Usual Care or Usual Care. Treatment satisfaction will be assessed at 3-months; sleep disturbance and sleep-related impairment, disability and functioning, and health-related quality of life will be assessed at baseline, 3-months, and 6-months to determine measure responsiveness and provide preliminary insight into treatment effects.
Of note, information provided in this entry (e.g., design, eligibility criteria, outcomes, etc.) pertains only to Aim 3 which includes the pilot randomized trial. Consistent with Stage I of the NIH stage model of behavioral intervention development research, results from Aim 1 and 2 activities may lead to modifications to the pilot protocol and procedures in Aim 3.
- Being tested
- Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation
- Keywords
- Veterans, Cardiac Rehabilitation
- Medical subject headings
- Sleep Wake Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitationBehavioural
Also called TranS-C
Participants will complete the TranS-C intervention as adapted for cardiac rehabilitation. TranS-C is a behavioral intervention that is rooted in basic sleep and circadian science and draws from empirically-supported treatments including Cognitive Behavioral Therapy for Insomnia (CBT-I), Interpersonal and Social Rhythm Therapy (IPSRT), chronotherapy, and light therapy. It was designed to promote sleep health across a range of sleep problems. Participants in this group will also continue to receive care as usual, cardiac/sleep-related or otherwise.
| Study group | Role | What they receive |
|---|---|---|
| TranS-C + Usual Care | Experimental | Participants in this group will receive TranS-C and will continue with care in cardiac rehabilitation as usual. Receives: Behavioral: Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation |
| Usual Care | No intervention | Participants in this group will receive only usual care and thus will continue with care in cardiac rehabilitation as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Treatment Satisfaction Measure
Self-report measure of patient satisfaction with behavioral intervention process and outcomes. Subscale scores range from 0-4. Higher scores are suggestive of greater satisfaction with treatment.
Measured: 3 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0-Sleep Disturbance 8a from Baseline to 3 and 6 months
Validated self-report measure of global sleep disturbance over the preceding 7 days. Produces raw score and T-score values, where 50 is the mean of the reference population and 10 is the standard deviation.
Higher scores are indicative of greater sleep disturbance.
Measured: Baseline to 3 and 6 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0-Sleep Related Impairment 8a from Baseline to 3 and 6 months
Validated self-report measure of sleep-related impairment over the preceding 7 days. Produces raw score and T-score values, where 50 is the mean of the reference population and 10 is the standard deviation. Higher scores are indicative of greater sleep-related impairment.
Measured: Baseline to 3 and 6 months
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) from Baseline to 3 and 6 months
Validated self-report measure of disability and functioning associated with physical and mental disorders. The WHODAS 2.0 contains 36-items that assess functioning in the domains of cognition, mobility, self-care, getting along, life activities, and participation over the preceding 30 days. The outcome of interest is the WHODAS 2.0 summary score. Using the complex scoring method, scores range from 0 to 100. Higher scores are indicative of greater disability.
Measured: Baseline to 3 and 6 months
MacNew Heart Disease Health-Related Quality of Life Questionnaire (MacNew) from Baseline to 3 and 6 months
Validated self-report measure of health-related quality of life in patients with heart disease. Contains 27 items that assess physical limitations, emotional function, social function, and symptoms common in heart disease (e.g., angina/chest pain, shortness of breath, fatigue, aching legs). The outcome of interest is the total health-related quality of life score. Scores range from 1 to 7. Higher scores are indicative of higher levels of health-related quality of life.
Measured: Baseline to 3 months and 6 months
Secondary outcomes (4)
Short Physical Performance Battery (SPPB) from Baseline to 3 and 6 months
Validated performance-based measure of physical function. Includes assessments of gait speed, functional strength, and standing balance. Total scores range from 0 to 12. Higher scores are indicative of better performance.
Measured: Baseline to 3 and 6 months
Physical Performance Test (PPT)from Baseline to 3 and 6 months
Validated performance-based measure of physical functioning. Requires participants to perform 7 activities that simulate activities of daily living (e.g., writing a sentence, putting on a jacket). Scores range from 0 to 28. Higher scores are indicative of better performance.
Measured: Baseline to 3 and 6 months
Life Space Assessment from Baseline to 3 and 6 months
Validated self-report measure of life space mobility (i.e., the spatial area in which a person navigates). Respondents indicate how far and how often they have traveled to various places (e.g., in immediate neighborhood, outside immediate town or community) in the past 4 weeks. Composite scores range from 0 to 120. Higher scores are suggestive of greater life space mobility.
Measured: Baseline to 3 and 6 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF) from Baseline to 3 and 6 months
Validated self-report measure of quality of life. Contains 26 items that assess and yield scores representative of quality of life in the domains of physical health, psychological health, social relationships, and environment. Domain scores range from 0 to 100. Higher scores are indicative of higher quality of life.
Measured: Baseline to 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start27 Jan 2022
- Primary completion16 Apr 2023
- Study completion16 Apr 2023
Why it stopped: Principal Investigator leaving institution. Aim 3 was not initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Wake DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized trial with participants assigned to one of two groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Caitlan A. Tighe, PhD MA, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506112
- Sponsor's protocol ID
- E3393-W
- Other IDs
- RX003393
- Status last verified
- May 2023
- First submitted
- 5 Aug 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final data sets underlying publications resulting from the proposed research may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics
- ClinicalTrials.gov ID
- NCT04506112
- Acronym / sponsor ID
- E3393-W
- Keywords
- Veterans, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator leaving institution. Aim 3 was not initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 16 Apr 2023 (actual)
- Study completion
- 16 Apr 2023 (actual)
- First posted
- 10 Aug 2020 (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 study aims are to: 1) optimize the Transdiagnostic Sleep and Circadian Intervention (TranS-C) for delivery to Veterans in cardiac rehabilitation, 2) test and refine the adapted TranS-C treatment manual and protocol, and 3) conduct a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures.
Detailed description
Aim 1 will involve formative work to optimize the TranS-C manual and protocol for delivery in Cardiac Rehabilitation, with input from Veterans and provider stakeholders. Aim 2 will involve a preliminary test and refinement of the adapted TranS-C manual and protocol with a small sample of Veterans who are participating in cardiac rehabilitation and report sleep disturbance and/or sleep-related impairment. Aim 3 will involve a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures. Veterans in cardiac rehabilitation with sleep disturbance and/or sleep-related impairment will be randomized to TranS-C + Usual Care or Usual Care. Treatment satisfaction will be assessed at 3-months; sleep disturbance and sleep-related impairment, disability and functioning, and health-related quality of life will be assessed at baseline, 3-months, and 6-months to determine measure responsiveness and provide preliminary insight into treatment effects.
Of note, information provided in this entry (e.g., design, eligibility criteria, outcomes, etc.) pertains only to Aim 3 which includes the pilot randomized trial. Consistent with Stage I of the NIH stage model of behavioral intervention development research, results from Aim 1 and 2 activities may lead to modifications to the pilot protocol and procedures in Aim 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized trial with participants assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| TranS-C + Usual Care | Experimental | Behavioral: Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitationParticipants in this group will receive TranS-C and will continue with care in cardiac rehabilitation as usual. |
| Usual Care | No intervention | –Participants in this group will receive only usual care and thus will continue with care in cardiac rehabilitation as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Veteran
- Age 18 years or older
- Referred for VAPHS cardiac rehabilitation
- Self-reported sleep disturbance or sleep-related impairment, determined by PROMIS Sleep Disturbance T-score at least 55 (raw score at least 25) or PROMIS Sleep-Related Impairment T-score at least 55 (raw score at least 20)
- English language fluency
Key exclusion criteria (7 listed)
- Moderate to severe cognitive impairment
- Active suicidal ideation, plan, or intent
- Current moderate to severe alcohol or substance use disorder
- Current severe symptoms of depression, anxiety, mania/hypomania, psychosis, or PTSD
- Currently engaged in a non-pharmacological intervention for sleep
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 |
|---|---|---|
| Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitationAlso: TranS-CParticipants will complete the TranS-C intervention as adapted for cardiac rehabilitation. TranS-C is a behavioral intervention that is rooted in basic sleep and circadian science and draws from empirically-supported treatments including Cognitive Behavioral Therapy for Insomnia (CBT-I), Interpersonal and Social Rhythm Therapy (IPSRT), chronotherapy, and light therapy. It was designed to promote sleep health across a range of sleep problems. Participants in this group will also continue to receive care as usual, cardiac/sleep-related or otherwise. | Behavioural | TranS-C + Usual Care |
Primary outcome
Multidimensional Treatment Satisfaction Measure
Time frame: 3 months
Self-report measure of patient satisfaction with behavioral intervention process and outcomes. Subscale scores range from 0-4. Higher scores are suggestive of greater satisfaction with treatment.
Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0-Sleep Disturbance 8a from Baseline to 3 and 6 months
Time frame: Baseline to 3 and 6 months
Validated self-report measure of global sleep disturbance over the preceding 7 days. Produces raw score and T-score values, where 50 is the mean of the reference population and 10 is the standard deviation. Higher scores are indicative of greater sleep disturbance.
Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0-Sleep Related Impairment 8a from Baseline to 3 and 6 months
Time frame: Baseline to 3 and 6 months
Validated self-report measure of sleep-related impairment over the preceding 7 days. Produces raw score and T-score values, where 50 is the mean of the reference population and 10 is the standard deviation. Higher scores are indicative of greater sleep-related impairment.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) from Baseline to 3 and 6 months
Time frame: Baseline to 3 and 6 months
Validated self-report measure of disability and functioning associated with physical and mental disorders. The WHODAS 2.0 contains 36-items that assess functioning in the domains of cognition, mobility, self-care, getting along, life activities, and participation over the preceding 30 days. The outcome of interest is the WHODAS 2.0 summary score. Using the complex scoring method, scores range from 0 to 100. Higher scores are indicative of greater disability.
MacNew Heart Disease Health-Related Quality of Life Questionnaire (MacNew) from Baseline to 3 and 6 months
Time frame: Baseline to 3 months and 6 months
Validated self-report measure of health-related quality of life in patients with heart disease. Contains 27 items that assess physical limitations, emotional function, social function, and symptoms common in heart disease (e.g., angina/chest pain, shortness of breath, fatigue, aching legs). The outcome of interest is the total health-related quality of life score. Scores range from 1 to 7. Higher scores are indicative of higher levels of health-related quality of life.
4 secondary outcomes
Short Physical Performance Battery (SPPB) from Baseline to 3 and 6 months
Time frame: Baseline to 3 and 6 months
Physical Performance Test (PPT)from Baseline to 3 and 6 months
Time frame: Baseline to 3 and 6 months
Life Space Assessment from Baseline to 3 and 6 months
Time frame: Baseline to 3 and 6 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF) from Baseline to 3 and 6 months
Time frame: Baseline to 3 and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Yes. Final data sets underlying publications resulting from the proposed research may be shared.
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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.
Caitlan A. Tighe, PhD MA principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation in people with Sleep Wake Disorders and Sleep Disturbance, run by VA Office of Research and Development 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 9 inclusion and 7 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: withdrawn, as of the sponsor's last update on 10 May 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Multidimensional Treatment Satisfaction Measure (time frame: 3 months). The study lists 5 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 10 May 2023.