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Tests sleep treatments in older adults with memory decline and sleep trouble

Compares two sleep treatments in older adults with memory decline and sleep problems.

Key facts

Who runs it
New York State Psychiatric Institute
Where
New York, United StatesSee the site
Trial code
Registry title
Sleep Interventions and Neurocognitive Outcomes
Status
Not yet recruiting
People taking part
50 people, planned
Started
1 Aug 2026
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Acoustic slow-wave activity enhancement
  • Cognitive behavioral therapy for insomnia
Record updated
3 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for older adults with amnestic mild cognitive impairment (a memory problem) and sleep trouble. It tests two sleep treatments.

Age
60 to 85 years.
Sex
All sexes can join.
Disease stage
Amnestic mild cognitive impairment, plus sleep disturbance (a score of 8 or greater on the Insomnia Severity Index at baseline, without sleep medications).
Earlier treatment
People who regularly use sleep medicines (more than 3 times per week) cannot join. People who use them 3 times a week or less will be asked to stop before the baseline visit.
Biomarker or test result
Telephone MMSE (T-MMSE) score of 22 or greater at screening. Aim of the memory tests: confirm aMCI with the Logical Memory test and the Quick Dementia Rating Scale.

Main reasons for not taking part

  • Stroke, or very high risk of heart and blood vessel disease
  • Neurologic disease such as epilepsy, MS, movement disorders or brain injury
  • Sleep disorders other than insomnia, such as moderate-severe sleep apnea
  • Use of benzodiazepine medicines or antidepressants with strong anticholinergic effects
  • Moderate to severe depression, or no family member or other person to act as informant

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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)
  • Presence of subject memory complains not exclusionary. Presence of subjective memory complaints without objective signs of impairment (T-MMSE, QDRS, LM) would not be considered as the presence of late MCI or dementia, therefore are not exclusionary
  • 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
  • Have access to stable internet connection
  • A family member or other individual who is in contact with the subject and consents to serve as informant during the study; this can be a telephone informant in the case of subjects who do not have a live-in informant

Who cannot take part

  • Use of antidepressants with known large anticholinergic properties will be excluded. These include: amitriptyline, amoxapine, clomipramine, desipramine, doxepine, imipramine, isocarboxazide, lithium, maprotiline, mirtazapine, nortriptyline, tranylcypromine trimipramine, and phenelzine. Other medications are allowed during the study and are not exclusionary
  • Participants taking medications with benzodiazepines properties will be excluded. These include: diazepam, quazepam, estazolam, alprazolam, clorazepate, clorazepate, oxazepam, alprazolam, chlordiazepoxide, lorazepam, flurazepam, triazolam, temazepam, and midazolam
  • Participants with moderate to severe depression (Geriatric Depression Scale>8) will be excluded from the study and will be encouraged to seek treatment for their symptoms. Participants with moderate depression (GDS 5-8) will be encouraged to return for screening after receiving treatment and seeing improvement in their symptoms
  • Diagnosis of stroke or excessive risk of CVD
  • Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loc)
  • Untreated diabetes
  • Active treatment of cancer
  • Presence of sleep disorders other than insomnia (moderate-severe sleep apnea, REM-behavior disorder, restless legs syndrome, circadian rhythm disorder). Mild sleep apnea will not be exclusionary
  • Current DSM-5 Axis I psychiatric diagnosis of schizophrenia, schizoaffective disorder, substance/alcohol use disorder, or bipolar disorder
  • Telephone MMSE score below 22 (Newkirk et al., 2004) and Logical Memory above 11 for subjects with 16 or more years of education, 9 for subjects with 8-15 years of education, and 6 for subjects with 0-7 years of education
  • Participants who are unable to provide an informant

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 60 and 85 years old?

Where in United States

  • New York State Psychiatric InstituteNew York, United StatesContact: Hyun Kim, PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Cognitive Behavioral Therapy for InsomniaExisting treatment, for comparison

    Participants assigned to the CBTI treatment group will receive 8 weeks of weekly telehealth sessions with a masters-level therapist. Each session is approximately 50 minutes in duration.

  • Acoustic Slow-Wave Activity EnhancementExisting treatment, for comparison

    Participants assigned to the SWAE group will be instructed to use the Next Sense Earbuds at least four nights out of seven nights of the week.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Sleep Interventions and Neurocognitive Outcomes in Amnestic Mild Cognitive Impairment
Plain-language title
Tests sleep treatments in older adults with memory decline and sleep troubleGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05987007, who can take part
Record updated
3 August 2026