Not Yet RecruitingNot Applicable

Sleep Interventions and Neurocognitive Outcomes

United States50 participantsStarted 2026-05-01

Plain-language summary

This protocol focuses on the effect of sleep interventions on improving sleep and building cognitive/brain resilience in older adults with amnestic mild cognitive impairment and sleep disturbance. Two sleep interventions, cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE), will be utilized in a pilot randomized clinical trial in which participants are randomized to different treatment groups (CBTI or SWAE). Participants will be assessed over a 6-month period in order to examine the impact of sleep treatments on neuropsychological outcomes and cognitively mediated everyday functioning.

Who can participate

Age range60 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. English speaking participants, ages 60-85 years
✓. Telephone MMSE (T-MMSE) score of 22 or greater at screening assessment; T-MMSE \<18 during post-treatment visit or 6-month follow-up will be discontinued from participation of the study.
✓. Individuals with aMCI, as determined by the Wechsler Memory Scale-Revised Logical Memory Delayed Recall (LM) and Quick Dementia Rating Scale (QDRS)

Exclusion criteria

✕. Participants with regular and consistent use of sleep medications (sedatives/hypnotic use of \>3 times per week) will be excluded. Participants who take sleep medications 3 or less times per week will be asked to discontinue medications prior to the study baseline visit. All discontinuation/tapering procedures will require PI's direct consultation with participants' prescribing or primary care physicians, which will be documented to ensure participants' safety.
✕. Presence of sleep disturbance, as determined by score of 8 or greater on the Insomnia Severity Index administered at baseline (without sleep medications).
✕. Participants must have capacity to provide informed consent.
✕

What they're measuring

No Practice Effect (NPE) battery

Timeframe: Baseline, Week 9, Week 24

Everyday Cognition (ECog)

Timeframe: Baseline, Week 9, Week 24

Conners Continuous Performance Test (CPT-3)

Timeframe: Baseline, Week 9, Week 24

Trial details

NCT IDNCT05987007

SponsorNew York State Psychiatric Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Hyun Kim, PhD

646-774-8459 HK3141@cumc.columbia.edu

View on ClinicalTrials.gov More Sleep Disturbance trials

Plain-language summary

Who can participate

Age range60 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. English speaking participants, ages 60-85 years
✓. Telephone MMSE (T-MMSE) score of 22 or greater at screening assessment; T-MMSE \<18 during post-treatment visit or 6-month follow-up will be discontinued from participation of the study.
✓. Individuals with aMCI, as determined by the Wechsler Memory Scale-Revised Logical Memory Delayed Recall (LM) and Quick Dementia Rating Scale (QDRS)

Exclusion criteria

✕. Participants with regular and consistent use of sleep medications (sedatives/hypnotic use of \>3 times per week) will be excluded. Participants who take sleep medications 3 or less times per week will be asked to discontinue medications prior to the study baseline visit. All discontinuation/tapering procedures will require PI's direct consultation with participants' prescribing or primary care physicians, which will be documented to ensure participants' safety.
✕. Presence of sleep disturbance, as determined by score of 8 or greater on the Insomnia Severity Index administered at baseline (without sleep medications).
✕. Participants must have capacity to provide informed consent.
✕