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NCT05987007Not yet recruiting

Sleep Interventions and Neurocognitive Outcomes

Sleep Interventions and Neurocognitive Outcomes in Amnestic Mild Cognitive Impairment

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
22 May 2023
Start date
1 Aug 2026
Primary completion date
31 Dec 2028
Lead sponsor
New York State Psychiatric Institute
NCT number
NCT05987007

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 1 Aug 2026 to the primary completion date, 31 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
New York State Psychiatric Institute
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.