What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for insomnia, particularly those similar to the sleep intervention studied for improving sleep quality and potentially reducing cognitive decline and Aβ deposition, include pharmacologic agents like trazodone and nonpharmacologic interventions. Trazodone, although used for sleep disturbances, can have side effects such as dizziness, dry mouth, and potential cardiovascular issues. Nonpharmacologic interventions, such as cognitive-behavioral therapy for insomnia (CBT-I), generally have fewer side effects but may require more time and patient commitment. Overall, while pharmacologic treatments can be effective, they often come with a risk of adverse effects, making nonpharmacologic approaches a safer long-term option.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of insomnia, including benzodiazepines (e.g., temazepam), non-benzodiazepine sleep aids (e.g., zolpidem, eszopiclone), and melatonin receptor agonists (e.g., ramelteon). These medications primarily aim to improve sleep quality. While the Sleep Intervention trial focuses on improving cognitive function and reducing Aβ deposition through sleep enhancement, there are no specific FDA-approved insomnia treatments explicitly targeting cognitive decline or Aβ reduction. However, improving sleep quality is a recognized strategy to potentially mitigate cognitive decline.

What other types of research exist?

Promising novel alternatives to sleep interventions for insomnia patients in 2024 include: 1) Amyloid-ß-directed immunotherapy, which targets the Aβ peptide central to Alzheimer's pathogenesis. 2) Melatonin-based therapies, including melatonin-containing hybrid molecules, melatonin analogues, and melatonin derivatives, which have shown neuroprotective effects in preclinical studies. 3) Cholinergic receptor agonists and drugs aimed at decreasing β-amyloid, which are under investigation for their potential to modify disease progression and improve cognitive function.

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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, 6-week reassessment, and one-year reassessment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a sleep improvement program for older adults with insomnia. It aims to see if better sleep can enhance memory and reduce brain changes related to Alzheimer's disease.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and one-year assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and one-year assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and one-year assessment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Continuous Performance Test (CPT)

Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

+1 more

Secondary study objectives

Polysomnography

Other study objectives

Apolipoprotein E (APOE) 4 Genotyping

Coin in Hand

Florbetapir PET Imaging

+8 more

Awards & Highlights

No Placebo-Only Group

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

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

0 / 6Eligibility criteria met

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.