Not yet recruitingNot applicable

Sleep Interventions and Neurocognitive Outcomes

Sleep Interventions and Neurocognitive Outcomes in Amnestic Mild Cognitive Impairment

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two sleep treatments for adults ages 60–85 with mild memory problems and trouble sleeping. The treatments are therapy for insomnia (trouble sleeping) and sounds meant to boost deep sleep. People are assigned by chance to a treatment group and followed for 6 months to check sleep, thinking, and daily skills.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Speak English and be 60–85 years old.
  • Have amnestic mild cognitive impairment, meaning mild memory problems, based on study tests.
  • Score at least 22 on a phone test of memory and thinking. Participation ends if the score falls below 18 after treatment or at 6 months.
  • Have sleep problems, with a score of at least 8 on the study’s insomnia survey while not taking sleep medicine.
  • If you take sleep medicine up to 3 times a week, stop before the first study visit. The study doctor must work with your doctor to do this safely.
  • Be able to understand the study and agree to join.
  • Have a stable internet connection.
  • Have a family member or someone else who knows you agree to give information during the study. They may do this by phone.

Who can't join

  • Have had a stroke, have a high risk of heart or blood vessel disease, have untreated diabetes, or are being treated for cancer.
  • Have a nervous system disease, such as a movement disorder, multiple sclerosis, epilepsy, or a brain injury that caused more than 15 minutes of unconsciousness.
  • Have memory or thinking test scores outside the study’s limits. Some memory score limits depend on years of schooling.
  • Have certain sleep problems besides insomnia, such as moderate to severe sleep apnea (breathing pauses), acting out dreams, restless legs, or problems with your sleep schedule. Mild sleep apnea is allowed.
  • Currently have schizophrenia, schizoaffective disorder, bipolar disorder, or an alcohol or drug use disorder.
  • Take sleep medicine more than 3 times a week, certain listed antidepressants or lithium, or benzodiazepine medicines, such as diazepam or lorazepam.
  • Score above 8 on the study’s depression survey. People scoring 5–8 are encouraged to get treatment and return for screening after symptoms improve.
  • Cannot provide someone who agrees to give information about you during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. English speaking participants, ages 60-85 years 2. 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. 3. Individuals with aMCI, as determined by the Wechsler Memory Scale-Revised Logical Memory Delayed Recall (LM) and Quick Dementia Rating Scale (QDRS) 4. 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. 5. 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. 6. Presence of sleep disturbance, as determined by score of 8 or greater on the Insomnia Severity Index administered at baseline (without sleep medications). 7. Participants must have capacity to provide informed consent. 8. Have access to stable internet connection. 9. 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 Exclusion Criteria: 1. Diagnosis of stroke or excessive risk of CVD 2. Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loc) 3. Untreated diabetes 4. Active treatment of cancer 5. 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 6. 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. 7. Current DSM-5 Axis I psychiatric diagnosis of schizophrenia, schizoaffective disorder, substance/alcohol use disorder, or bipolar disorder 8. 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. 9. 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. 10. 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. 11. Participants who are unable to provide an informant.

Study sites (1)

NY