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Sleep Therapies for Alzheimer's Disease

N/A

Recruiting

Led By Andrea Goldstein-Piekarski, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Subjective complaint of sleep disturbance ≥ 3 months in duration

Subjective complaint of insomnia associated with daytime impairment or distress (ISI ≥ 10)

Must not have

Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to complete the assessments, or are unable and/or unlikely to follow the study protocols

Current or lifetime history of bipolar disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to test a model in which sleep disruption contributes to neuropsychiatric symptoms through impairments in emotion regulation function in individuals at risk for AD. If successful, this study will provide critical insight into the mechanisms by which sleep disturbance may increase risk for developing AD.

Who is the study for?

This trial is for adults aged 50-90 with sleep disturbances and mild cognitive impairment or early-stage Alzheimer's, experiencing neuropsychiatric symptoms like anxiety or depression. Participants must live near Stanford University, have stable medication use, and a caregiver to assist them. Exclusions include severe mental health risks, substance abuse, certain medical conditions, previous specific therapies for insomnia within the last year, and unvaccinated individuals.

What is being tested?

The study tests whether treating sleep problems can improve emotional distress in those at risk of or with early Alzheimer's Disease. It involves two treatments: Desensitization Therapy (DT-I) and Cognitive Behavioral Therapy (CBT-I), which includes mindfulness and sleep hygiene education. The effects on brain function related to emotion regulation will be measured using fMRI scans.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of CBT-I may include temporary increases in daytime sleepiness due to sleep restriction techniques used during therapy sessions.

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 for at least 3 months.

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I often struggle to sleep and it affects my day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe issues with my vision, hearing, or hand movement that could prevent me from following the study's requirements.

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I have been diagnosed with bipolar disorder.

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I had psychosis before my memory problems started.

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I either don't use my CPAP machine as recommended or have moderate to severe untreated sleep apnea.

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I have had a mild brain injury with unconsciousness for over 5 minutes.

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I have a history of falls or severe difficulty moving around.

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I do not have any severe, uncontrolled health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Fronto-limbic function

Insomnia symptoms

Neuropsychiatric Symptoms

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: Cognitive Behavioral Therapy for Insomina (CBT-I)Experimental Treatment1 Intervention

CBT-I improves sleep through a combination of behavioral interventions (stimulus control (SC), sleep restriction (SR)), cognitive therapy (CT) as well as additional components such as mindfulness training and sleep hygiene education. SC is an intervention that re-establishes the connection between the bed/bedroom with sleep to help develop a more consistent sleep/wake pattern. SR leads to higher quality sleep by reducing excessive time spent in bed to the actual amount of sleep, thereby creating mild sleep deprivation and increasing the homeostatic sleep drive. Like CT for other disorders, CT for insomnia targets maladaptive thoughts and cognitions that may interfere with sleep.

Group II: Desensitization Therapy for Insomnia (DT-I)Active Control1 Intervention

DT-I is a quasidesensitization treatment presented as a means of eliminating the "conditioned arousal," which prolongs nocturnal awakenings. DT-I has been validated as an active-placebo control condition. Therapists help each DT-I recipient develop a chronological 12-item hierarchy of common activities he/she does on awakening at night (e.g., opening eyes, clock watching). Therapists also help them develop 6 imaginal scenes of themselves engaged in neutral activities (e.g., reading the newspaper). Each session, DT-I recipients are taught to pair neutral scenes with items on the 12-item hierarchy so, by the end of the sixth session, all hierarchy items have been practiced with therapist assistance. Each session, the exercise is tape recorded and the patient is given this tape locked in a player. The patients are told to practice their exercises at home once each day, no less than 2 hours before bedtime, but to avoid using the tape or exercise during sleep periods.

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 / 9Eligibility criteria met