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Sleep Management for Muscle Weakness
N/A
Recruiting
Led By Lance Bollinger, PhD
Research Sponsored by Lance Bollinger
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18 and 50 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and study completion, approximately 14 days
Awards & highlights
Study Summary
This trial will test how sleep and no bearing weight on leg affects muscle strength & posture. Participants will sleep & walk on one leg & do tests & imaging. Researchers will compare adequate sleep & restricted sleep to see effects.
Who is the study for?
This trial is for adults aged 18-50 who exercise regularly, including both aerobic (>150min/week) and resistance exercises (>1 time/week), and sleep at least 7 hours nightly. It's not for those with recent injuries, certain medical conditions like heart arrhythmias or muscle disorders, pregnant women, or individuals on sleep medications.Check my eligibility
What is being tested?
Researchers are testing how lack of sleep combined with non-weight bearing on one leg affects muscle strength and balance. Participants will have different sleep schedules while using only one leg to walk. They'll undergo tests for posture control, muscle strength, and get their muscles imaged.See study design
What are the potential side effects?
While the study itself may not directly cause side effects beyond normal discomfort from exercise or fatigue due to sleep restriction, potential indirect side effects could include increased tiredness, mood changes, decreased alertness and performance impairment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and study completion, approximately 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and study completion, approximately 14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Interpolated Twitch
Change in Single Leg Land and Hold
Change in Single Leg Stand (SLS)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep Restriction (SR)Experimental Treatment1 Intervention
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SR group will sleep only 5 hours for three consecutive nights.
Group II: Sleep Adequate (SA)Active Control1 Intervention
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SA group will sleep for 9 hours for three consecutive nights.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Restriction
2016
N/A
~470
Find a Location
Who is running the clinical trial?
Lance BollingerLead Sponsor
National Aeronautics and Space Administration (NASA)FED
24 Previous Clinical Trials
1,746 Total Patients Enrolled
Lance Bollinger, PhDPrincipal InvestigatorUniversity of Kentucky
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a heart, lung, kidney, or metabolic disease.You have taken birth control pills in the last three months.I have an irregular heartbeat.You have been pregnant within the last 6 months.You do not typically sleep for 7 to 9 hours each night.I am between 18 and 50 years old.I have been diagnosed with a sleep disorder.This criterion means that participants need to sleep for at least 7 hours every night.You have been doing aerobic exercise for more than 150 minutes per week and resistance exercise at least once a week for the past year.Your waist size is smaller than 55cm or larger than 90cm (for females) or smaller than 75cm or larger than 100cm (for males).I have undergone gender-affirming therapy.I've had a muscle, bone, or joint injury in the last 6 months that limits my movement.I am either younger than 18 or older than 50 years old.I am a woman under 150 cm or a man under 170 cm, or I am over 190 cm tall.Your body mass index is too low (less than 18.5) or too high (more than 27.5).I have a blood clotting disorder.You have not been exercising regularly for the past year.Your blood pressure is higher than 140 over 90 when you are resting.I have not had a low back or leg injury in the last 6 months.I am taking medication to help me sleep.I have a neurological condition like MS or Parkinson's affecting my balance.
Research Study Groups:
This trial has the following groups:- Group 1: Sleep Restriction (SR)
- Group 2: Sleep Adequate (SA)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research trial permit individuals aged 50 and over to participate?
"The requirements for applicants of this trial are between 18 and 50 years old. There are 87 studies specifically designed to serve those under the age of eighteen, while 201 cater towards seniors aged 65 or higher."
Answered by AI
Is it possible for me to register as a participant in this medical study?
"Potentially eligible patients for this medical trial should display signs of muscular diminishment and fall between the ages 18 to 50. So far, 20 participants have been accepted."
Answered by AI
How many participants are currently undergoing the clinical trial?
"Affirmative. Clinicaltrials.gov has the latest information that this trial, initially posted on August 5th 2023, is actively recruiting for participants. The search parameters are set to find approximately 20 patients at a single site."
Answered by AI
Are there still openings for volunteers in this trial?
"This clinical trial is presently in the recruitment phase, with its initial post being on August 5th 2023 and its most recent update occurring on July 21st of the same year."
Answered by AI
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