Sleep Interventions for Sleep Disorders

N/A

Waitlist Available

Led By Hyun Kim, PhD

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 9, week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore how sleep interventions can help improve sleep and cognitive functioning in elderly people with mild memory problems and sleep issues.

Who is the study for?

This trial is for English-speaking adults aged 60-85 with mild cognitive impairment and sleep disturbances. They must score at least 22 on a memory screening, have internet access, and an informant to participate. Excluded are those with certain neurological diseases, untreated diabetes, active cancer treatment, other sleep disorders besides insomnia, severe psychiatric conditions or depression.

What is being tested?

The study tests two sleep treatments: Cognitive Behavioral Therapy for Insomnia (CBTI) and Acoustic Slow-Wave Activity Enhancement (SWAE). Participants will be randomly assigned to one of these interventions and monitored over six months to see how the treatments affect their brain function and daily living skills.

What are the potential side effects?

While specific side effects are not detailed in this summary, typical side effects from such non-pharmacological interventions may include discomfort during therapy sessions or temporary changes in sleeping patterns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 9, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 9, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 9, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Conners Continuous Performance Test (CPT-3)

Everyday Cognition (ECog)

No Practice Effect (NPE) battery

Secondary study objectives

Insomnia Severity Index

N3 sleep stage ("slow-wave sleep")

Objective Total Sleep Time

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Cognitive Behavioral Therapy for InsomniaActive Control1 Intervention

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.

Group II: Acoustic Slow-Wave Activity EnhancementActive Control1 Intervention

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.

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