NM Balance Regulation With ULLS and Loss of Sleep (NCT05956964) | Clinical Trial Compass
CompletedNot Applicable
NM Balance Regulation With ULLS and Loss of Sleep
United States16 participantsStarted 2023-08-10
Plain-language summary
The goal of this trial is to learn about how restricted sleep and not bearing weight on the leg affects muscle strength and posture control. Participants will walk exclusively on one leg, sleep at differing intervals, and complete posture tests, muscle strength tests, and muscle imaging. Researchers will compare adequate sleep and restricted sleep to see if muscle strength and posture are affected.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 50 years
* Regularly engaging in aerobic exercise (\> 150min/wk) and resistance exercise (\>1 time per week) for the past 12 months
* Regularly sleep at least 7 hours per night
Exclusion Criteria:
* Age \< 18 or \> 50 years
* Height between \<150 (F) or \<170 (M) and \> 190 cm (both sexes)
* Waist circumference \< 55cm or \> 90cm (F) and \< 75cm or \> 100cm (M)
* Body mass index \< 18.5 or \> 27.5
* Do not regularly sleep between 7 and 9 hours each night
* Have a known sleep disorder
* Not regularly engaging in exercise for previous 12 months
* Blood clotting disorder
* Heart arrhythmia
* Implanted device which could negatively be affected by electrical impulse or strong magnetic field such as pacemaker, internal defibrillator, or cochlear implant
* Diagnosed cardiovascular, pulmonary, renal, or metabolic disease
* Pregnancy (within previous 6 months)
* Oral contraceptive use (within previous three months)
* High resting blood pressure (\>140 systolic and/or \> 90 diastolic)
* Currently or previously undergone gender-affirming therapy (hormone therapy or sexual reassignment surgery)
* Low back or leg injury in previous 6 months
* Currently taking medication to assist with sleep
* Muscle, bone, or joint injury that limits physical activity within previous 6 months
* Neurological disorder which affects balance (such as multiple sclerosis or Parkinson's disease)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Percentage in Interpolated Twitch Torque of the Loaded and Unloaded Leg
Timeframe: Baseline and study completion, approximately 14 days
2
Percent Change in Single Leg Stand (SLS)
Timeframe: Baseline and study completion, approximately 14 days
3
Muscle Volume
Timeframe: Post-intervention, approximately 14 days after start of study
4
Percent Change in Center of Pressure Velocity During Single Leg Stance
Timeframe: Baseline and study completion, approximately 14 days