Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-02 @ 12:02 AM
Study NCT ID:
NCT06969066
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2025-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Memory Training in Insomnia With Cognitive Impairment
Sponsor:
Xuanwu Hospital, Beijing
Organization:
Study Overview
Official Title:
Effect of Cognitive Remediation Therapy (CRT) for Chronic Insomnia (CI) With Cognitive Impairment
Status:
RECRUITING
Status Verified Date:
2025-05
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 randomized controlled trial investigates the effects of Cognitive Remediation Therapy (CRT) on chronic insomnia (CI) with mild cognitive impairment.
Detailed Description:
Chronic insomnia (CI) is a prevalent sleep disorder that not only causes night-time sleep difficulties but also impairs daytime functioning and cognitive abilities, including deficits in attention, memory, and executive function. Persistent insomnia may diminish the brain's information processing capacity, affecting memory, attention, and decision-making. CRT, a structured cognitive training intervention, has been shown in psychiatric populations to enhance memory, attention, and executive function by promoting neuroplasticity, neurotransmitter modulation, and optimizing brain activity patterns.
Applying CRT to CI patients may similarly support cognitive recovery and indirectly improve sleep quality. However, empirical evidence remains limited.
This randomized controlled trial will enroll 70 patients with CI and cognitive decline. Participants will be randomly assigned to either a CRT plus Sleep Hygiene Education (SHE) group or an SHE-only group (n=35 each). The CRT intervention will last 6 weeks, with daily 50-minute sessions. Evaluations will occur at baseline, post-intervention, and at 3, 6, and 12 months follow-up. This study aims to provide evidence for CRT as a treatment for CI with cognitive impairment and inform future clinical practices.
Applying CRT to CI patients may similarly support cognitive recovery and indirectly improve sleep quality. However, empirical evidence remains limited.
This randomized controlled trial will enroll 70 patients with CI and cognitive decline. Participants will be randomly assigned to either a CRT plus Sleep Hygiene Education (SHE) group or an SHE-only group (n=35 each). The CRT intervention will last 6 weeks, with daily 50-minute sessions. Evaluations will occur at baseline, post-intervention, and at 3, 6, and 12 months follow-up. This study aims to provide evidence for CRT as a treatment for CI with cognitive impairment and inform future clinical practices.
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?: