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Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation for Sleep Wake Disorder

N/A

Waitlist Available

Led By Caitlan A. Tighe, PhD MA

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 and 6 months

Awards & highlights

Study Summary

This trial is testing a new sleep intervention for Veterans in cardiac rehab, to see if it improves sleep and other outcomes.

Eligible Conditions

Sleep Wake Disorder
Sleep Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MacNew Heart Disease Health-Related Quality of Life Questionnaire (MacNew) from Baseline to 3 and 6 months

Multidimensional Treatment Satisfaction Measure

Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0-Sleep Disturbance 8a from Baseline to 3 and 6 months

+2 more

Secondary outcome measures

Life Space Assessment from Baseline to 3 and 6 months

Physical Performance Test (PPT)from Baseline to 3 and 6 months

Short Physical Performance Battery (SPPB) from Baseline to 3 and 6 months

+1 more

Other outcome measures

Insomnia Severity Index from Baseline to 3 and 6 months

Pittsburgh Sleep Quality Index from Baseline to 3 and 6 months

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TranS-C + Usual CareExperimental Treatment1 Intervention

Participants in this group will receive TranS-C and will continue with care in cardiac rehabilitation as usual.

Group II: Usual CareActive Control1 Intervention

Participants in this group will receive only usual care and thus will continue with care in cardiac rehabilitation as usual.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,603 Total Patients Enrolled

Caitlan A. Tighe, PhD MAPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this medical trial still ongoing?

"Indeed, according to clinicaltrials.gov, this medical experiment has resumed recruitment since it was initially posted on January 27th 2022 and revised as of August 23rd 20202. 100 individuals are needed from 1 medical centre for the trial's participation."

Answered by AI

What objectives are researchers aiming to accomplish with this trial?

"The primary endpoint of this 3-month trial is to measure the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0 - Sleep Disturbance 8a from Baseline to three and six months. Other outcomes that will be evaluated include, but are not limited to, Duke Activity Status Index (DASI), World Health Organization Quality of Life-BREF (WHOQOL-BREF), and Life Space Assessment at all time points mentioned previously."

Answered by AI

What is the total enrollment figure of this research protocol?

"Affirmative. As per records on clinicaltrials.gov, this medical research is currently recruiting patients; the trial was first posted on January 27th 2022 and most recently updated in August of that year. The aim is to enroll 100 participants at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

2022. "Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04506112.