Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375265
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-07
Brief Title:
Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients SLEEP-BOOST
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
SLEEP-BOOST
Brief Summary:
The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients SLEEP-BOOST is a pilot randomized controlled singled-blinded participant trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia CBT-I mobile application paired with a wearable device wrist actigraphy
Detailed Description:
CBT-I is the frontline treatment for insomnia but is not considered for preoperative care of older surgical patients with insomnia who are at risk of perioperative neurocognitive disorders associated with sleepcircadian dysfunction We propose to determine if digital CBT-I dCBT-I is feasible for treating older surgical patients with insomnia symptoms and to examine the effects of dCBT-I on sleep cognitive trajectory mood pain activity and function after surgery The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients SLEEP-BOOST is a pilot randomized controlled singled-blinded participant trial in major orthopedic joint surgery patients that will build on a previously clinically tested CBT-I mobile application paired with a wearable device wrist actigraphy
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