Ignite Creation Date:
2024-05-06 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05299723
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2022-03-15
Brief Title:
The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
A Pilot Chronotherapeutic Intervention to Improve Sleep Following Acute Coronary Syndrome The SleepWell Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 21 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 eg 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 activitysleep 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 21 ratio to CC condition or control condition All participants ie those in the CC and control groups will wear an activitysleep 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
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 eg 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 activitysleep 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 21 ratio to CC condition or control condition All participants ie those in the CC and control groups will wear an activitysleep 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30AG064198-02 | NIH | None | httpsreporternihgovquickSearchP30AG064198-02 |