NCT06969066

Memory Training in Insomnia With Cognitive Impairment

Effect of Cognitive Remediation Therapy (CRT) for Chronic Insomnia (CI) With Cognitive Impairment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cognitive Therapy/Methods
• Insomnia Chronic
• Cognitive Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE)	Participants will receive Cognitive Remediation Therapy (CRT) combined with Sleep Hygiene Education (SHE). CRT includes structured training sessions targeting attention, memory, visuospatial skills, calculation ability, logical reasoning, and language abilities. Sessions will be conducted daily for 50 minutes over 6 weeks. Sleep Hygiene Education will cover standard recommendations to improve sleep behaviors.
BEHAVIORAL	Sleep Hygiene Education Only (SHE)	Participants will receive Sleep Hygiene Education (SHE) only, including guidance on adjusting sleep schedules, maintaining healthy sleep environments, minimizing stimulant intake, and managing sleep-related behaviors, without any CRT intervention.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2025-05-13
• Last updated: 2025-05-28

Locations

1 site across 1 country: China