Sleep DisturbanceNCT05299723
The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
A study testing BLT Intervention, BLB Intervention and Sleep Hygiene Education in people with Sleep Disturbance and Insomnia, run by Columbia University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance, Insomnia, Acute Coronary Syndrome
- What is being tested?
- BLT Intervention, BLB Intervention and Sleep Hygiene Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 26 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 18 years of age or older,
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Show all 23Show fewer
- 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:
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Chronotherapeutic Intervention to Improve Sleep Following Acute Coronary Syndrome: The SleepWell Study
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.
Read the 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.
- Conditions
- Sleep Disturbance, Insomnia, Acute Coronary Syndrome
- Being tested
- BLT Intervention, BLB Intervention, Sleep Hygiene Education
- Keywords
- sleep, light therapy, chronotherapy, circadian, cardiovascular, insomnia, short sleep duration, intervention, acute coronary syndrome
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLT InterventionBehavioural
Also called Bright light therapy intervention
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.
BLB InterventionBehavioural
Also called Blue light blocking intervention
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.
Sleep Hygiene EducationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Behavioral: Sleep Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At end of 4-week intervention period
Secondary outcomes (3)
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).
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
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.)"
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start18 Apr 2022
- Primary completion27 Feb 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ari Shechter, Columbia University
- Investigators
- Ari Shechter, PhD, Principal investigator, Associate Professor of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299723
- Sponsor's protocol ID
- AAAU0150
- Other IDs
- P30AG064198-02
- Status last verified
- Dec 2024
- First submitted
- 15 Mar 2022
- Last updated
- 7 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40028185
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Chronotherapeutic Intervention to Improve Sleep Following Acute Coronary Syndrome: The SleepWell Study
- ClinicalTrials.gov ID
- NCT05299723
- Acronym / sponsor ID
- AAAU0150
- Conditions
- Sleep Disturbance, Insomnia, Acute Coronary Syndrome
- Keywords
- sleep, light therapy, chronotherapy, circadian, cardiovascular, insomnia, short sleep duration, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Posted 7 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase A - open label single-arm | Experimental | Behavioral: BLT Intervention, Behavioral: BLB Intervention, Behavioral: Sleep Hygiene EducationAll 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). |
| Phase B - active CC treatment | Experimental | Behavioral: BLT Intervention, Behavioral: BLB Intervention, Behavioral: Sleep Hygiene EducationFor 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. |
| Phase B - sleep hygiene education control group | Active comparator | Behavioral: Sleep Hygiene EducationAll Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLT InterventionAlso: Bright light therapy interventionBLT 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. | Behavioural | Phase A - open label single-arm, Phase B - active CC treatment |
| BLB InterventionAlso: Blue light blocking interventionBLB 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. | Behavioural | Phase A - open label single-arm, Phase B - active CC treatment |
| Sleep Hygiene EducationThe 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). | Behavioural | Phase A - open label single-arm, Phase B - active CC treatment, Phase B - sleep hygiene education control group |
Primary outcome
Percentage 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.
Percentage 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 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.
Percentage 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 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.
Percentage 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 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.
Percentage 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 (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.
Percentage of Who Report Administering the BLT Intervention on ≥50% 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.
Percentage of Who Report Administering the BLT Intervention on ≥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 ≥75% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.
Percentage of Who Report Administering the BLB Intervention on ≥50% 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.
Percentage of Who Report Administering the BLB Intervention on ≥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 ≥75% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.
3 secondary outcomes
Difference in the Total Score of Insomnia Severity Index
Time frame: Baseline, 4 weeks
Difference in the Total Global Score of Pittsburgh Sleep Quality Index
Time frame: Baseline, 4 weeks
Difference in the Sleep Duration Item of the Pittsburgh Sleep Quality Index (i.e., Question #4).
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40028185Mendieta 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.
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Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ari Shechter, PhD principal investigator
Associate Professor of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLT Intervention, BLB Intervention and Sleep Hygiene Education in people with Sleep Disturbance and Insomnia, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion (time frame: At end of 4-week intervention period). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05299723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.