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Procedure

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Conners Continuous Performance Test (CPT-3)

Everyday Cognition (ECog)

No Practice Effect (NPE) battery

Secondary outcome measures

Insomnia Severity Index

N3 sleep stage ("slow-wave sleep")

Objective Total Sleep Time

+3 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor

475 Previous Clinical Trials

153,857 Total Patients Enrolled

Columbia UniversityOTHER

1,431 Previous Clinical Trials

2,460,781 Total Patients Enrolled

Hyun Kim, PhDPrincipal InvestigatorColumbia University/ New York State Psychiatric Institute

1 Previous Clinical Trials

547 Total Patients Enrolled

Media Library

Acoustic Slow-Wave Activity Enhancement (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05987007 — N/A

Mild Cognitive Impairment Research Study Groups: Cognitive Behavioral Therapy for Insomnia, Acoustic Slow-Wave Activity Enhancement

Mild Cognitive Impairment Clinical Trial 2023: Acoustic Slow-Wave Activity Enhancement Highlights & Side Effects. Trial Name: NCT05987007 — N/A

Acoustic Slow-Wave Activity Enhancement (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05987007 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this trial still in progress?

"As of the current date, this trial is accepting applicants. It was initially posted on February 15th 2023 and underwent its most recent modification on August 3rd 2023 as indicated by clinicaltrials.gov."

Answered by AI

Is this research project amenable to my participation?

"To qualify for this trial, sleep disorder sufferers aged between 60 and 85 must apply. Thus far, 50 people have been recruited to participate in the experiment."

Answered by AI

How many participants are currently participating in this clinical experiment?

"Affirmative. The details on clinicaltrials.gov demonstrate that this medical experiment, which was initially advertised on February 15th 2023, is actively recruiting patients. There are 50 spots open at one trial site for potential participants."

Answered by AI

Does the age criterion of this experimental project extend beyond forty-five years?

"According to the eligibility guidelines, eligible patients must be between 60 and 85 years old. The database houses 51 trials for minors and 653 studies are available to those above 65."

Answered by AI

What results are expected to be seen from this experiment?

"This trial will be supervised over a period of Baseline, Week 9 and Week 24. Its primary aim is to assess Everyday Cognition (ECog). Secondary objectives include quantifying N3 Sleep Stage with the help of Dreem Headband sleep assessment technology as well as ascertaining Subjective Total Sleep Time from self-reported sleep diaries and Objective Total Sleep Time via an external monitoring device."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleep Interventions and Neurocognitive Outcomes

Hyun "Monica" Kim 2024. "Sleep Interventions and Neurocognitive Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05987007.

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