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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
Can write, speak and read English or Spanish (for PHASE B)
18 years of age or older
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 below
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I can communicate effectively in English or Spanish.
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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 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.
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I often get less than 6 hours of sleep or have insomnia.
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I often have trouble sleeping or sleep less than 6 hours most nights.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks for reporting.

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 more
Secondary 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
1,424 Previous Clinical Trials
2,473,008 Total Patients Enrolled
9 Trials studying Acute Coronary Syndrome
3,732 Patients Enrolled for Acute Coronary Syndrome
National Institute on Aging (NIA)NIH
1,655 Previous Clinical Trials
28,004,151 Total Patients Enrolled
2 Trials studying Acute Coronary Syndrome
534 Patients Enrolled for Acute Coronary Syndrome
Ari Shechter, PhDPrincipal InvestigatorAssistant Professor of Medical Sciences

Media Library

Sleep Hygiene Education Clinical Trial Eligibility Overview. Trial Name: NCT05299723 — N/A
Acute Coronary Syndrome Research Study Groups: Phase B - active CC treatment, Phase A - open label single-arm, Phase B - sleep hygiene education control group
Acute Coronary Syndrome Clinical Trial 2023: Sleep Hygiene Education Highlights & Side Effects. Trial Name: NCT05299723 — N/A
Sleep Hygiene Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT05299723 — N/A

Frequently Asked Questions

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

What is the current sample size of this research project?

"Affirmative, the data hosted on clinicaltrials.gov attests to this medical study's current requirement for 20 participants from 1 centre. The trial was initially posted April 18th 2022 and recently updated May 4th 2022."

Answered by AI

Are new participants being recruited for this trial at present?

"Affirmative. According to clinicaltrials.gov, patient recruitment for this medical trial is currently underway; it was first posted on April 18th 2022 and was most recently modified on May 4th 2022. The study requires 20 participants from a single clinic."

Answered by AI

Who else is applying?

What state do they live in?
California
New York
How old are they?
18 - 65
What site did they apply to?
CUIMC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~2 spots leftby May 2024