Sleep Interventions and Neurocognitive Outcomes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorNew York State Psychiatric Institute
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Acoustic slow-wave activity enhancement
- Cognitive behavioral therapy for insomnia
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
New York State Psychiatric Institute
Lead sponsor
Columbia University
Collaborator
Source ClinicalTrials.gov