The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS

NCT05299723 | Completed Results DMC

• 2 other identifiers: AAAU0150P30AG064198-02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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), administered daily for 4 weeks in patients who experienced acute coronary syndrome (ACS). Phase A of the study will be a single-arm open-label study of the home-based CC intervention in 5 post-ACS patients. Phase B of the study will be a parallel-arm randomized clinical trial (RCT) in which 15 post-ACS patients will be randomized (using a 2:1 allocation) to active CC treatment or sleep hygiene education control group. In Phase A and Phase B, the primary aims are study feasibility, acceptability, appropriateness, and usability. In Phase B, the investigator will additionally assess whether the intervention engages its proposed proximal target mechanism - sleep.

Conditions

Sleep Disturbance; Insomnia; Acute Coronary Syndrome

Keywords

sleep; light therapy; chronotherapy; circadian; cardiovascular; insomnia; short sleep duration; intervention; acute coronary syndrome

Outcome Measures

Primary Outcomes (9)

• Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion

  The total number of participants who complete all endpoint questionnaire assessments will be documented and the proportion of participants who fully complete outcome assessments will be computed.

  At end of 4-week intervention period

• Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility

  Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the Feasibility of Intervention Measure (FIM). The FIM is a 4-item questionnaire, with each question having a 5-point Likert scale (1=completely disagree to 5= completely agree). The score is calculated by adding up the selections on each of the 4 questions. The total score on the FIM can range from 4 to 20, with higher scores indicating greater feasibility of the intervention.

  At end of 4-week intervention period

• Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability

  Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the Acceptability of Intervention Measure (AIM). The AIM is a 4-item questionnaire, with each question having a 5-point Likert scale (1=completely disagree to 5= completely agree). The score is calculated by adding up the selections on each of the 4 questions. The total score on the AIM can range from 4 to 20, with higher scores indicating greater acceptability of the intervention.

  At end of 4-week intervention period

• Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Sleep

  Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the Intervention Appropriateness Measure (IAM). The IAM is a 4-item questionnaire, with each question having a 5-point Likert scale (1=completely disagree to 5= completely agree). The score is calculated by adding up the selections on each of the 4 questions. The total score on the IAM can range from 4 to 20, with higher scores indicating greater feasibility of the intervention.

  At end of 4-week intervention period

• Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability

  Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the System Usability Scale (SUS). The SUS is a 10-item questionnaire with a 5-point Likert scale (1= strongly disagree to 5 = strongly agree). The score is calculated by subtracting 1 from each question's raw score then using the following equation: SUS = 2.5 (20 + \[sum of scores on SUS1, SUS3, SUS5, SUS7, SUS9\] - \[sum of scores on SUS2, SUS4, SUS6, SUS8, SUS10\]). The SUS total score can range from 0 to 100, with higher scores indicating better system usability of the intervention.

  At end of 4-week intervention period

• Percentage of Who Report Administering the BLT Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period

  Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥50% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.

  At end of 4-week intervention period

• Percentage of Who Report Administering the BLT Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period

  Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥75% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.

  At end of 4-week intervention period

• Percentage of Who Report Administering the BLB Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period

  Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥50% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.

  At end of 4-week intervention period

• Percentage of Who Report Administering the BLB Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period

  Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥75% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.

  At end of 4-week intervention period

Secondary Outcomes (3)

• Difference in the Total Score of Insomnia Severity Index

  Baseline, 4 weeks

• Difference in the Total Global Score of Pittsburgh Sleep Quality Index

  Baseline, 4 weeks

• Difference in the Sleep Duration Item of the Pittsburgh Sleep Quality Index (i.e., Question #4).

  Baseline, 4 weeks

Study Arms (3)

Phase A - open label single-arm

EXPERIMENTAL

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).

Behavioral: BLT Intervention; Behavioral: BLB Intervention; Behavioral: Sleep Hygiene Education

Phase B - active CC treatment

EXPERIMENTAL

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.

Behavioral: BLT Intervention; Behavioral: BLB Intervention; Behavioral: Sleep Hygiene Education

Phase B - sleep hygiene education control group

ACTIVE COMPARATOR

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.

Behavioral: Sleep Hygiene Education

Interventions

BLT Intervention BEHAVIORAL

BLT will be administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.

Also known as: Bright light therapy intervention

Phase A - open label single-arm; Phase B - active CC treatment

BLB Intervention BEHAVIORAL

BLB will be administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.

Also known as: Blue light blocking intervention

Phase A - open label single-arm; Phase B - active CC treatment

Sleep Hygiene Education BEHAVIORAL

The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).

Phase A - open label single-arm; Phase B - active CC treatment; Phase B - sleep hygiene education control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• years of age or older,
• can write, speak and read English or Spanish,
• provider and patient confirmed ACS,

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

CUIMC

New York, New York, 10032, United States

Location

Related Publications (1)

• Mendieta M, Cumella R, Fray N, Lopez-Veneros D, Hiti D, Franqui C, D'Agostino C, Kronish IM, Shechter A. Combined Chronotherapy for Poor Sleep Following Acute Coronary Syndrome: A Pilot Randomized Trial. J Circadian Rhythms. 2025 Feb 25;23:1. doi: 10.5334/jcr.250. eCollection 2025.

  PMID: 40028185 DERIVED

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Ari Shechter
• Organization: Columbia University Irving Medical Center

as4874@cumc.columbia.edu

212-342-1335

Study Officials

• Ari Shechter, PhD

  Associate Professor of Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medical Sciences

Model Details: This will be a two-phase pilot study. Phase A of the study will be a single-arm open-label study of the home-based CC intervention in n=5 post-ACS patients. Please note that as Phase A is a single-arm open-label study, there will be no randomization of participants. Phase B of the study will be a parallel-arm randomized clinical trial (RCT) in which n=15 post-ACS patients will be randomized (using a 2:1 allocation) to active CC treatment or sleep hygiene education control group. The "Allocation" scheme below refers to Phase B.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 29, 2022
• Study Start: April 18, 2022
• Primary Completion: February 27, 2024
• Study Completion: June 26, 2024
• Last Updated: January 7, 2025
• Results First Posted: January 7, 2025

Record last verified: 2024-12

Locations

US (1)