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Chronotherapy for Sleep Disorders After Acute Coronary Syndrome
N/A
Waitlist Available
Led By Ari Shechter, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
presence of insomnia symptoms based on the Insomnia Symptoms Questionnaire, or frequently (3-4 times per week) or always (5-7 times per week) experiencing short sleep duration of 6 hours or less per night.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks
Awards & highlights
Study Summary
This trial will test a "combined chronotherapy" intervention consisting of morning bright light therapy and evening blue light blocking, administered daily for 4 weeks in patients who experienced acute coronary syndrome. The primary aims are study feasibility, acceptability, appropriateness, and usability.
Who is the study for?
This trial is for adults who've had an acute coronary syndrome (ACS) event within the last 3 months and are experiencing insomnia. Participants must be able to communicate in English, with Phase B also allowing Spanish speakers. Exclusions include severe chronic conditions, certain eye diseases, bipolar disorder, night shift workers, those on light-sensitive medications or anti-depressants/anxiety meds.Check my eligibility
What is being tested?
The SleepWell Study tests a 'combined chronotherapy' intervention for improving sleep post-ACS. It involves morning bright light therapy and evening blue light blocking over four weeks. The study has two phases: an initial single-arm phase followed by a randomized trial comparing this treatment to sleep hygiene education.See study design
What are the potential side effects?
Potential side effects may include discomfort from bright or blue light exposure such as eyestrain or headache. There's also a risk of triggering manic episodes in individuals with undiagnosed bipolar disorder due to the bright light therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I often have trouble sleeping or sleep less than 6 hours most nights.
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I had a heart problem within the last 3 months.
Select...
I often get less than 6 hours of sleep or have insomnia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants who complete 100% of the outcome assessments at study conclusion
Proportion of participants who report scores ≥4 for their final rating of the intervention's acceptability
Proportion of participants who report scores ≥4 for their final rating of the intervention's appropriateness for improving sleep
+3 moreSecondary outcome measures
Difference in the sleep duration item of the Pittsburgh Sleep Quality Index (i.e., Question #4).
Difference in the total global score of Pittsburgh Sleep Quality Index
Difference in the total score of Insomnia Severity Index
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Phase B - active CC treatmentExperimental Treatment3 Interventions
For all Phase B participants randomized to the active CC group, BLT will occur each morning after awakening and will last for 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group will also receive a sleep hygiene education.
Group II: Phase A - open label single-armExperimental Treatment3 Interventions
All Phase A participants randomized to the home-based CC intervention will be use a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and use orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
Group III: Phase B - sleep hygiene education control groupActive Control1 Intervention
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Hygiene Education
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,438 Previous Clinical Trials
2,448,776 Total Patients Enrolled
9 Trials studying Acute Coronary Syndrome
3,732 Patients Enrolled for Acute Coronary Syndrome
National Institute on Aging (NIA)NIH
1,692 Previous Clinical Trials
28,027,195 Total Patients Enrolled
3 Trials studying Acute Coronary Syndrome
553 Patients Enrolled for Acute Coronary Syndrome
Ari Shechter, PhDPrincipal InvestigatorAssociate Professor of Medical Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have eye diseases like glaucoma or retinopathy.I do not have reliable access to a phone or email.I can communicate effectively in English or Spanish.I am currently taking medication for depression or anxiety.I am taking medications that make my skin more sensitive to light.I am 18 years old or older.You are unable to see.I do not speak Spanish.You work at night.The healthcare provider and the patient have confirmed acute coronary syndrome (ACS).The healthcare provider and patient have confirmed acute coronary syndrome (ACS).I often have trouble sleeping or sleep less than 6 hours most nights.I had a heart problem within the last 3 months.I often get less than 6 hours of sleep or have insomnia.You have a history of bipolar disorder or have shown signs of bipolar disorder in a questionnaire.I am able to follow the study's requirements without any issues.I had a heart problem within the last 3 months.You can participate in PHASE A of the trial if you meet the following requirements.I do not speak English.Both the healthcare provider and the patient have confirmed acute coronary syndrome (ACS).
Research Study Groups:
This trial has the following groups:- Group 1: Phase B - active CC treatment
- Group 2: Phase A - open label single-arm
- Group 3: Phase B - sleep hygiene education control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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