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The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS

Primary Purpose

Sleep Disturbance, Insomnia, Acute Coronary Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BLT Intervention

BLB Intervention

Sleep Hygiene Education

About this trial

This is an interventional supportive care trial for Sleep Disturbance focused on measuring sleep, light therapy, chronotherapy, circadian, cardiovascular, insomnia, short sleep duration, intervention, acute coronary syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients will be eligible for PHASE A if they meet the following criteria

Inclusion 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 Criteria:

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.

Exclusion Criteria:

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 and non-Spanish 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).

Sites / Locations

CUIMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Phase A - open label single-arm

Phase B - active CC treatment

Phase B - sleep hygiene education control group

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

Proportion 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.

Proportion 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 a 5-point Likert scale (completely disagree to completely agree).

Proportion 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 a 5-point Likert scale (completely disagree to completely agree).

Proportion 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 a 5-point Likert scale (completely disagree to completely agree).

Proportion 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 (strongly disagree to strongly agree).

Proportion of who report administering the intervention (i.e., morning BLT and evening BLB) on ≥50% (and ≥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 ≥50% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed. (Similar calculations will be done with a criteria of using intervention devices on 75% of days).

Secondary Outcome Measures

Difference in the total score of Insomnia Severity Index

This is to measure the baseline-to-study conclusion change in insomnia symptom severity. The range of values is 0-28, with higher values indicating worsened severity of insomnia symptoms. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

Difference in the total global score of Pittsburgh Sleep Quality Index

This is to measure the baseline-to-study conclusion change in global sleep quality. The Pittsburgh Sleep Quality Index is a 19-item questionnaire that is completed by the participant. The score range is 0-21. Higher score indicates poorer sleep quality. A cutoff value of a total score > 5 is often used to indicate the presence of poor sleep quality.

Difference in the sleep duration item of the Pittsburgh Sleep Quality Index (i.e., Question #4).

This is to measure the baseline-to-study conclusion change in self-reported sleep duration (hours spent asleep). Participants enter a value as a whole number in response to the question: "During the past month, how many hours of actual sleep did you get at night? (This may be different than the number of hours you spend in bed.)"

Full Information

NCT ID

NCT05299723

First Posted

March 15, 2022

Last Updated

May 12, 2023

Sponsor

Columbia University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT05299723

Brief Title

The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS

Official Title

A Pilot Chronotherapeutic Intervention to Improve Sleep Following Acute Coronary Syndrome: The SleepWell Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 18, 2022 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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 chronotherapeutic intervention targeting disturbed sleep in survivors of ACS. There are many ways to try and improve sleep. Some of these include taking medications or working with a trained sleep specialist. The goal of this research study is to investigate the usefulness of a new way of trying to improve sleep (an "intervention") that does not involve taking medications or working with a specialist or therapist. Chronotherapeutic interventions are non-pharmacologic approaches that target the circadian or sleep-wake cycle to improve behavioral or health outcomes. Light is the strongest external signal for the human circadian system and manipulations of the light environment (e.g., morning bright light exposure and evening light avoidance) are effective in improving sleep and mood. Participants in Phase A of this study will be asked to use a light visor to administer light to the eye each morning (BLT component of the CC) and orange-colored glasses to block out short wavelength ("blue") light to the eye each night before going to bed (BLB component of the CC) for 4 weeks. Participants are also asked to wear an activity/sleep monitor throughout the 4-week period and complete questionnaires about their sleep. Participants will also receive a sleep hygiene education by watching educational videos. In Phase B of the study, participants will be randomized to either the active CC intervention condition (consisting of both the BLT and BLB components along with sleep hygiene education) or a sleep hygiene education only control condition. Participants will be randomized in a 2:1 ratio to CC condition or control condition. All participants (i.e., those in the CC and control groups) will wear an activity/sleep monitor throughout the 4-week period and complete questionnaires about their sleep. There will also be a 3 month follow up after the end of the 4-week intervention period for both groups where we assess sleep outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disturbance, Insomnia, Acute Coronary Syndrome

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phase A - open label single-arm

Arm Type

Experimental

Arm Description

Arm Title

Phase B - active CC treatment

Arm Type

Experimental

Arm Description

Arm Title

Phase B - sleep hygiene education control group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

BLT Intervention

Other Intervention Name(s)

Bright light therapy intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

BLB Intervention

Other Intervention Name(s)

Blue light blocking intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Sleep Hygiene Education

Intervention Description

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).

Primary Outcome Measure Information:

Title

Proportion of participants who complete 100% of the outcome assessments at study conclusion

Description

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.

Time Frame