Sleep Interventions and Neurocognitive Outcomes

Part of paid clinical trials in New York, New York.

Sponsor
New York State Psychiatric Institute
Study ID
NCT05987007
Status
Not Yet Recruiting

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Conditions

  • Amnestic Mild Cognitive Impairment
  • Sleep Disturbance

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Acoustic slow-wave activity enhancement — DEVICE
    The acoustic enhancement of slow-wave activity will be conducted using the Dreem2 headband. This device utilizes five dry-EEG electrodes (O1, O2, FpZ, F7, and F8), a 3D accelerometer, and a pulse oximeter to detect slow-wave activity and generates acoustic stimulation of slow-waves to augment slow-wave sleep.
  • Cognitive behavioral therapy for insomnia — BEHAVIORAL
    Cognitive behavioral therapy for insomnia (CBTI) is a well-established first-line or complimentary treatment for insomnia which consists of cognitive and behavioral modifications, including addressing maladaptive sleep-related behaviors, controlling sleep environment, and limiting time spent in bed.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cognitive Behavioral Therapy for Insomnia
    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.
  • Active Comparator: Acoustic Slow-Wave Activity Enhancement
    Participants assigned to the SWAE group will be instructed to use the Dreem2 headband at least four nights out of seven nights of the week.

Primary Outcome Measure

No Practice Effect (NPE) battery [ Time Frame: Baseline, Week 9, Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York State Psychiatric InstituteNew YorkNew York10032
Hyun Kim, PhD
[email protected]
646-774-8691
Hyun Kim, PhD (PRINCIPAL_INVESTIGATOR)
Terry E Goldberg, PhD (SUB_INVESTIGATOR)

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By research site
New York State Psychiatric Institute· New York, NY

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