- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05299723
The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
A Pilot Chronotherapeutic Intervention to Improve Sleep Following Acute Coronary Syndrome: The SleepWell Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- CUIMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase A - open label single-arm
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).
|
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.
Other Names:
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.
Other Names:
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).
|
Experimental: Phase B - active CC treatment
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.
|
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.
Other Names:
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.
Other Names:
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).
|
Active Comparator: Phase B - sleep hygiene education control group
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants who complete 100% of the outcome assessments at study conclusion
Time Frame: At end of 4-week intervention period
|
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
|
Proportion of participants who report scores ≥4 for their final rating of the intervention's feasibility
Time Frame: At end of 4-week intervention period
|
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).
|
At end of 4-week intervention period
|
Proportion of participants who report scores ≥4 for their final rating of the intervention's acceptability
Time Frame: At end of 4-week intervention period
|
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).
|
At end of 4-week intervention period
|
Proportion of participants who report scores ≥4 for their final rating of the intervention's appropriateness for improving sleep
Time Frame: At end of 4-week intervention period
|
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).
|
At end of 4-week intervention period
|
Proportion of participants who report total scores ≥68 for their final rating of the intervention's usability
Time Frame: At end of 4-week intervention period
|
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).
|
At end of 4-week intervention period
|
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
Time Frame: At end of 4-week intervention 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).
|
At end of 4-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in the total score of Insomnia Severity Index
Time Frame: Baseline, 4 weeks
|
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).
|
Baseline, 4 weeks
|
Difference in the total global score of Pittsburgh Sleep Quality Index
Time Frame: Baseline, 4 weeks
|
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.
|
Baseline, 4 weeks
|
Difference in the sleep duration item of the Pittsburgh Sleep Quality Index (i.e., Question #4).
Time Frame: Baseline, 4 weeks
|
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.)"
|
Baseline, 4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ari Shechter, PhD, Associate Professor of Medical Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAU0150
- P30AG064198-02 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insomnia
-
Leiden UniversityBioClock Consortium; Caring UniveristiesCompleted
-
National Science Council, TaiwanCompleted
-
Sunshine Lake Pharma Co., Ltd.Unknown
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
Massachusetts General HospitalNational Institutes of Health (NIH)Completed
-
IpsenCompletedThe Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over (QUALISLEEP)InsomniaRussian Federation
-
Charite University, Berlin, GermanyCompleted
-
Roxane LaboratoriesCompleted
-
Butler HospitalSunovionCompleted
Clinical Trials on BLT Intervention
-
VA Office of Research and DevelopmentRecruiting
-
Universidade da CoruñaCompletedDementia | Mood | BehaviorSpain
-
VA Office of Research and DevelopmentCompletedObstructive Sleep ApneaUnited States
-
Shanghai Ninth People's Hospital Affiliated to...Not yet recruitingTooth Loss | Partial-edentulism
-
Institut Straumann AGCompleted
-
Queen Mary University of LondonCompletedOsteoporosis, PostmenopausalUnited Kingdom
-
Erica OsbornTerminatedChronic Obstructive Pulmonary Disease | Depressive Symptoms | Cystic FibrosisUnited States
-
Cairo UniversityCompletedOral Mucositis (Ulcerative)Egypt
-
Milton S. Hershey Medical CenterSolta MedicalWithdrawn