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Sleep Schedule Restriction for Alzheimer's Disease (ALPS Trial)

N/A
Recruiting
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 65-85
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

ALPS Trial Summary

This trial will explore whether better sleep can help mitigate the effects of Alzheimer's disease.

Who is the study for?
This trial is for older adults aged 65-85 with sleep difficulties but without severe psychiatric conditions, heavy alcohol or caffeine consumption, CNS diseases like Alzheimer's, or certain medications that affect sleep. Participants should have normal vision and hearing (with aids if necessary), a tendency to wake up often at night, and not be involved in shift work.Check my eligibility
What is being tested?
The study tests whether restricting the time spent in bed can improve deep sleep and cognitive function in older adults. It aims to see if this intervention can reduce brain overactivity related to Alzheimer's disease risk by enhancing slow-wave activity during sleep.See study design
What are the potential side effects?
Since the intervention involves behavioral changes rather than medication, side effects may include increased tiredness due to restricted time in bed but are otherwise minimal compared to drug treatments.

ALPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 65 and 85 years old.

ALPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4 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
Amyloid positivity status
Change in mean Plasma amyloid-beta 1-42
Mean change in Hippocampal Activation
+3 more
Secondary outcome measures
Apolipoprotein (ApoE) e4 allele carrier status
Clinical insomnia status
Cognitive status based on neuropsychological adjudication
+7 more

ALPS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Time in Bed RestrictionExperimental Treatment2 Interventions
Time in Bed (TIB) restriction of 85% of habitual TIB.
Group II: ControlActive Control1 Intervention
Participants will follow their typical sleep schedule consistent with measured average sleep and wake times.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,225 Total Patients Enrolled
14 Trials studying Sleep
1,970 Patients Enrolled for Sleep
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,947 Total Patients Enrolled
9 Trials studying Sleep
973 Patients Enrolled for Sleep

Media Library

Time in Bed Restriction Clinical Trial Eligibility Overview. Trial Name: NCT05138848 — N/A
Sleep Research Study Groups: Control, Time in Bed Restriction
Sleep Clinical Trial 2023: Time in Bed Restriction Highlights & Side Effects. Trial Name: NCT05138848 — N/A
Time in Bed Restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05138848 — N/A
Sleep Patient Testimony for trial: Trial Name: NCT05138848 — N/A

Frequently Asked Questions

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

Does this research study accept participants who are younger than 25 years old?

"According to the trial's inclusion criteria, elderly adults between 65 and 85 years of age are eligible for enrollment."

Answered by AI

What is the maximum capacity for enrollees in this experiment?

"Affirmative. The particulars of the trial are accessible on clinicaltrials.gov, which confirms that it is presently seeking candidates to participate in this experiment; with its initial post date being 3rd January 2022 and last update occurring 25th October 2022. 116 participants must be sourced from a singular research facility."

Answered by AI

What are the eligibility criteria for participating in this research trial?

"This trial is recruiting 116 individuals with amyloidosis between 65 and 85 years of age. Eligibility for the study requires that participants have normal or corrected vision/hearing, a mean sleep efficiency below 90% as estimated by diary and actigraphy recordings, and wake time after initial falling asleep exceeding 20 minutes based on journal entries and activity tracking data."

Answered by AI

What aims is this investigation trying to reach?

"The primary purpose of this research is to assess overnight memory retention on the AB paired associate task and preclinical Alzheimer's cognitive composite score over baseline and 4 weeks. Secondary objectives include measuring changes in response time, accuracy, and sleep efficiency associated with executive function tasks as well as proportion of time spent sleeping while in bed."

Answered by AI

Are there open slots for the current clinical trial?

"Affirmative. According to the clinicaltrials.gov website, this investigation is actively seeking volunteers with a launch date of March 1st 2022 and an update on October 25th 2022. A total of 116 individuals must be recruited from one medical centre in order for the study to progress as planned."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Pennsylvania
What site did they apply to?
UPMC Western Psychiatric Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I do not want to progress to Alzheimer's disease.
PatientReceived 2+ prior treatments
~56 spots leftby May 2026