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Sleep Intervention + CBT for Insomnia

N/A
Waitlist Available
Led By Catherine Siengsukon, PT, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Report of difficulty falling asleep, maintaining sleep, or waking up too early at least three nights a week for the past six months
Be older than 18 years old
Must not have
Currently taking benzodiazepines, non-benzodiazepines, melatonin supplements, or agonists for insomnia
A known untreated sleep disorder (i.e., sleep apnea or restless leg syndrome)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and one-year assessment
Awards & highlights

Summary

This trial is testing whether a sleep intervention can improve cognitive function in older adults with insomnia symptoms, and whether it can reduce the rate of Aβ accumulation as measured by PET imaging.

Who is the study for?
Adults aged 60-85 with insomnia symptoms, who have trouble sleeping at least three nights a week for six months and score high enough on mental state exams to show no severe cognitive impairment or dementia. Excluded are those with untreated sleep disorders, severe depression, substance abuse history, certain mental illnesses or learning disabilities, current shift workers, or those already in CBT-I treatment.Check my eligibility
What is being tested?
The trial is testing whether a six-week program of Sleep and Lifestyle Education combined with Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve cognitive function and reduce brain amyloid deposits in older adults with insomnia. Some participants will also undergo PET imaging to track changes in amyloid levels over one year.See study design
What are the potential side effects?
While the study does not involve medication that typically has side effects, interventions like CBT-I may cause temporary increases in anxiety or stress due to changes in sleep patterns as individuals adjust to new behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had trouble sleeping at least three nights a week for the past six months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication or supplements for sleep problems.
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I have an untreated sleep disorder like sleep apnea or restless leg syndrome.
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I am currently undergoing cognitive behavioral therapy for insomnia.
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I cannot hear when people talk in a normal voice.
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I have a history of a nervous system disorder like stroke or Parkinson's.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6-week reassessment, and one-year reassessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6-week reassessment, and one-year reassessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Continuous Performance Test (CPT)
Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
+1 more
Secondary outcome measures
Polysomnography
Other outcome measures
Apolipoprotein E (APOE) 4 Genotyping
Coin in Hand
Florbetapir PET Imaging
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Six-Week CBT-I ProgramExperimental Treatment1 Intervention
CBT-I, six sessions, forty-five to sixty minutes in duration. Session 1: set up sleep restriction and stimulus control, discuss strategies for how to stay awake to a prescribed hour and what to do with wake after onset sleep time, provide sleep hygiene education. Session 2: determine if upward titration of total sleep time is warranted, review sleep hygiene. Session 3: continue upward titration of total sleep time, cognitive therapy for negative sleep beliefs if indicated. Session 4: continue upward titration of total sleep time, follow-up regarding negative sleep beliefs. Session 5: continue upward titration of total sleep time, discuss relapse prevention. Session 6: assess global treatment gains, discuss questions regarding relapse prevention.
Group II: Six-Week Sleep and Lifestyle Education ProgramActive Control1 Intervention
Sleep and Lifestyle Education, six sessions, forty-five to sixty minutes in duration. Session 1: Sleep education, Instruction/demonstration on stretching exercises. Session 2: Education on environmental factors & sleeping positions that impact sleep. Session 3: Education on lifestyle factors that impact sleep. Session 4: Education on diet and sleep. Session 5: Education on exercises and sleep. Session 6: Discus maintaining achievements & preventing relapses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia (CBT-I)
2014
N/A
~720

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cognitive Behavioral Therapy for Insomnia (CBT-I) is a common and effective treatment for insomnia that focuses on changing sleep habits and misconceptions about sleep. Key components include sleep education, stimulus control (using the bed only for sleep), sleep restriction (limiting time in bed to actual sleep time), and relaxation techniques to reduce anxiety. These interventions help re-establish a healthy sleep pattern, improve sleep quality, and reduce cognitive decline and Aβ deposition, as seen in the Sleep Intervention trial. This matters for insomnia patients as it addresses both the behavioral and psychological aspects of insomnia, leading to long-term improvements in sleep and overall cognitive health.
Three-Year Follow-Up Comparing Cognitive Behavioral Therapy for Depression to Cognitive Behavioral Therapy for Insomnia, for Patients With Both Diagnoses.The effect of acceptance and commitment therapy on insomnia and sleep quality: A systematic review.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
472 Previous Clinical Trials
171,239 Total Patients Enrolled
4 Trials studying Insomnia
231 Patients Enrolled for Insomnia
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,033,057 Total Patients Enrolled
9 Trials studying Insomnia
1,575 Patients Enrolled for Insomnia
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,750 Total Patients Enrolled
10 Trials studying Insomnia
918 Patients Enrolled for Insomnia

Media Library

Cognitive Behavioral Therapy for Insomnia (CBT-I) Clinical Trial Eligibility Overview. Trial Name: NCT03954210 — N/A
Insomnia Research Study Groups: Six-Week CBT-I Program, Six-Week Sleep and Lifestyle Education Program
Insomnia Clinical Trial 2023: Cognitive Behavioral Therapy for Insomnia (CBT-I) Highlights & Side Effects. Trial Name: NCT03954210 — N/A
Cognitive Behavioral Therapy for Insomnia (CBT-I) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03954210 — N/A
Insomnia Patient Testimony for trial: Trial Name: NCT03954210 — N/A
~34 spots leftby Jul 2025