Status:
COMPLETED
The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Sleep Disturbance
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This two-phase pilot study will test the feasibility of a "combined chronotherapy" (CC) intervention consisting of morning bright light therapy (BLT) and evening blue light blocking (BLB), administere...
Detailed Description
Survivors of acute medical events often experience psychological distress including post-traumatic stress disorder (PTSD). The goal of this project is to conduct preliminary testing of a chronotherape...
Eligibility Criteria
Inclusion
- Patients will be eligible for PHASE A if they meet the following criteria
- 18 years of age or older,
- can write, speak and read English,
- provider and patient confirmed ACS,
- ACS event occurred within the past 3 months, and
- 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.
Exclusion
- severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevent safe or adequate participation;
- deemed unable to comply with the protocol (either self-selected or indicated during screening that s/he/they could not complete all requested tasks). This includes, but is not limited to, patients with a level of cognitive impairment indicative of dementia, patients with current alcohol or substance abuse, and patients with severe mental illness (e.g., schizophrenia);
- unavailable for follow-up for reasons such as terminal illness and imminent plans to leave the United States (as we have migrant or mobile patients due to their citizenship and work issues);
- Non-English speaking;
- Lack of reliable phone or e-mail access;
- History of bipolar disorder (manic episode can be triggered by BLT) or positive screen for bipolar disorder based on the Mood Disorder Questionnaire;
- Eye disease including glaucoma or retinopathy (BLT contraindications);
- Blindness;
- Night shift work schedules;
- taking any anti-depressant or anti-anxiety medications; and
- taking other medications that increase sensitivity to light (by self-report).
- Patients will be eligible for PHASE B if they meet the following criteria:
- Inclusion Criteria:
- 18 years of age or older,
- can write, speak and read English or Spanish,
- provider and patient confirmed ACS,
- ACS event occurred within the past 3 months, and
- 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.
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05299723
Start Date
April 18 2022
End Date
June 26 2024
Last Update
January 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CUIMC
New York, New York, United States, 10032