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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
Must not have
Current use of sedating drugs used at bedtime
Severe obesity (BMI > 40)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 65 and 85 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I take medication to help me sleep at night.
Select...
My BMI is over 40, indicating severe obesity.
Select...
I have a long-term health issue that greatly impacts my sleep.
Select...
I had a car accident or a close call because of falling asleep in the last year.
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I have a history of serious brain or nervous system conditions.
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I am currently taking medication that affects my sleep.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Amyloid positivity status
Change in mean Plasma amyloid-beta 1-42
Mean change in Hippocampal Activation
+3 moreSecondary study objectives
Apolipoprotein (ApoE) e4 allele carrier status
Clinical insomnia status
Cognitive status based on neuropsychological adjudication
+7 moreAwards & 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: 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
1,789 Previous Clinical Trials
16,359,507 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,216 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a score higher than 10 on the Epworth sleepiness test.You drink more than 14 alcoholic drinks per week or more than 6 drinks at one time.You have a serious mental health condition like severe depression, panic disorder, substance abuse, or bipolar disorder.I take medication to help me sleep at night.You have a high sleep efficiency and wake up for less than 20 minutes during the night.You work at night or regularly between 12am and 6am.You are afraid of being in small or enclosed spaces.My BMI is over 40, indicating severe obesity.You can see and hear normally or with corrective lenses or aids.I have a long-term health issue that greatly impacts my sleep.You stop breathing or have shallow breathing more than 15 times in one night, as measured by a special test called Apnea Link Plus.You have trouble sleeping, as shown by your sleep diary and activity tracker, with a low sleep efficiency and long periods of being awake after falling asleep.I had a car accident or a close call because of falling asleep in the last year.You scored below 23 on a test that checks how well you can think and remember things over the phone.You drink more than 3 caffeinated drinks each day.I have a history of serious brain or nervous system conditions.I am currently taking medication that affects my sleep.You have metal inside your body.I am between 65 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Time in Bed Restriction
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05138848 — N/A
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