← Back to Search

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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have had trouble sleeping for at least 3 months.
Select...
I often struggle to sleep and it affects my day.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fronto-limbic function
Insomnia symptoms
Neuropsychiatric Symptoms

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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,445 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,617 Total Patients Enrolled
Andrea Goldstein-Piekarski, PhDPrincipal Investigator - Stanford University
Stanford University
2 Previous Clinical Trials
119 Total Patients Enrolled

Media Library

Desensitization Therapy for insomnia (DT-I) Clinical Trial Eligibility Overview. Trial Name: NCT04100057 — N/A
Alzheimer's Disease Research Study Groups: Desensitization Therapy for Insomnia (DT-I), Cognitive Behavioral Therapy for Insomina (CBT-I)

Frequently Asked Questions

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

How many individuals are involved with this research effort?

"Affirmative. According to the clinicaltrials.gov website, this research endeavour was initially announced on October 30th 2021 and is currently seeking patients for participation. 150 people are required at one site to continue with the trial's progress."

Answered by AI

Are individuals below the age of forty suitable for participating in this research?

"As per the qualifications for this study, only individuals between 50 and 90 years old are allowed to participate. Alternatively, there exists 86 trials designed specifically for minors and 1206 studies tailored towards senior citizens."

Answered by AI

Are there any openings for participation in this clinical investigation?

"Affirmative. The clinicaltrials.gov website reveals that this medical trial, which was created on October 30th 2021, is still recruiting patients. A total of 150 enrollees are desired at one location."

Answered by AI

Am I eligible to take part in this clinical investigation?

"Eligibility for this study is determined by the presence of Alzheimer's disease and an age range between 50-90 years old. Currently, roughly 150 individuals are being enrolled in the trial."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Andrea Goldstein-Piekarski, PhD
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have not tried other sleeping drugs except gabapentin but I still have severe insomnia which affects my quality of kife.
PatientReceived no prior treatments
I have not tried other sleeping drugs except gabapentin but I still have severe insomnia which affects my quality of life.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia
Andrea Goldstein-Piekarski 2022. "Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04100057.
All > Sleep Disorder > Alzheimers Disease
~57 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top