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Search / Trial NCT06969066

Memory Training in Insomnia With Cognitive Impairment

Launched by XUANWU HOSPITAL, BEIJING · May 5, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how a type of treatment called Cognitive Remediation Therapy (CRT) can help people who have chronic insomnia and mild cognitive impairment. Chronic insomnia is when someone has trouble sleeping for a long time, and cognitive impairment means they might be facing some memory or thinking challenges. The goal of the study is to see if this therapy can improve both sleep and cognitive function in participants.

To qualify for the trial, participants need to be between 55 and 75 years old, right-handed, and have a minimum of 12 years of education. They should also have sleep problems and some mild memory issues, but not have serious physical or mental health conditions that could interfere with the study. If eligible, participants will undergo CRT sessions aimed at enhancing their memory and sleep quality. It's important to know that the trial is currently recruiting, and all interested individuals will need to give their consent before joining.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Meets the diagnostic criteria for Insomnia Disorder according to DSM-5.
  • 2. Pittsburgh Sleep Quality Index (PSQI) total score \> 5.
  • 3. Age ≥ 8 years.
  • 4. Voluntary participation with signed informed consent.
  • 5. Meets the cognitive impairment criteria associated with CI:
  • (1) Right-handedness. (2) Age between 55 and 75 years. (3) Education duration ≥ 12 years. (4) At least junior high school education level; fulfills Petersen's diagnostic criteria for mild cognitive impairment: 1.Subjective complaints of memory decline. 2.Duration of cognitive complaints ≥ 3 months. 3.Assessment scores: Global Deterioration Scale (GDS) rating of stage 1-2; Clinical Dementia Rating (CDR) score of 0-0.5. 4.Memory test scores falling ≥ 1.5 standard deviations below the age- and education-matched norms: MMSE ≥ 24, MoCA \< 26, Activities of Daily Living (ADL) score \> 26. 5.Memory impairment as the primary deficit, with relatively preserved functioning in other cognitive domains.
  • 6.Normal daily functional abilities. 7.Exclusion of dementia or any major physical or psychiatric disorders that could impair brain function.
  • Exclusion Criteria:
  • 1. Presence of severe physical illnesses or major psychiatric disorders, or assessed risk of suicide.
  • 2. Diagnosed or suspected sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or currently engaged in shift work.
  • 3. Pregnancy or breastfeeding.
  • 4. Currently undergoing any form of psychological therapy.
  • 5. History of infectious diseases such as syphilis or HIV.

About Xuanwu Hospital, Beijing

Xuanwu Hospital, located in Beijing, is a leading clinical research institution renowned for its commitment to advancing medical knowledge and improving patient care. Affiliated with Capital Medical University, the hospital specializes in neurology and rehabilitation, providing a robust framework for innovative clinical trials. With a multidisciplinary team of experienced researchers and healthcare professionals, Xuanwu Hospital focuses on conducting high-quality, ethically sound studies that aim to explore new treatment modalities and enhance therapeutic outcomes. Through its dedication to research excellence and patient-centered approaches, Xuanwu Hospital plays a pivotal role in the advancement of healthcare solutions both locally and globally.

Locations

Beijing, , China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported