← Back to Search

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

Must not have

Diagnosed cardiovascular, pulmonary, renal, or metabolic disease

Heart arrhythmia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and study completion, approximately 14 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

I am between 18 and 50 years old.

Exclusion Criteria

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

Select...

I have been diagnosed with a heart, lung, kidney, or metabolic disease.

Select...

I have an irregular heartbeat.

Select...

I have been diagnosed with a sleep disorder.

Select...

I have undergone gender-affirming therapy.

Select...

I am either younger than 18 or older than 50 years old.

Select...

I am a woman under 150 cm or a man under 170 cm, or I am over 190 cm tall.

Select...

I have a blood clotting disorder.

Select...

I have not had a low back or leg injury in the last 6 months.

Select...

I am taking medication to help me sleep.

Select...

I have a neurological condition like MS or Parkinson's affecting my balance.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and study completion, approximately 14 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Interpolated Twitch

Change in Single Leg Land and Hold

Change in Single Leg Stand (SLS)

+1 more

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: 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

0 / 11Eligibility criteria met