Sleep Management for Muscle Weakness

Overseen By Lance Bollinger, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Lance Bollinger

Must not be taking: Sleep medications

Disqualifiers: Sleep disorder, Cardiovascular, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how sleep and walking on one leg affect muscle strength and posture. Participants will either sleep for 5 hours (Sleep Restriction) or 9 hours (Sleep Adequate) each night while using special shoes and crutches to walk on one leg. Researchers will track changes in muscle strength and balance between the two sleep groups. Ideal candidates exercise regularly and usually get at least 7 hours of sleep each night.

As an unphased trial, this study offers a unique opportunity to contribute to the scientific understanding of sleep and physical activity.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking medication to assist with sleep.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that getting very little sleep, such as only 3.6 hours, can sometimes cause sudden muscle weakness, known as cataplexy. However, this does not occur in everyone. Other studies suggest that insufficient sleep usually does not significantly affect muscle strength for most people. While long-term sleep deprivation might lead to loss of muscle mass and function, short-term sleep loss, like a few nights in this trial, is less likely to cause serious problems.

For the group receiving 9 hours of sleep, there is no risk of these issues, as adequate sleep generally helps maintain healthy muscles. Participants in both groups will use special shoes and crutches to assist with walking, which is part of the study's design to test muscle strength and posture. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different sleep patterns might affect muscle weakness, a novel approach compared to traditional treatments like physical therapy or medication. This trial tests whether restricting sleep or ensuring adequate sleep can influence muscle function, offering potential insights into how sleep duration impacts muscle health. By testing these sleep strategies, researchers hope to uncover new, non-invasive methods to manage muscle weakness, which could be a game-changer for those seeking alternatives to conventional treatments.

What evidence suggests that this trial's treatments could be effective for muscle weakness?

This trial will compare the effects of Sleep Restriction (SR) and Sleep Adequate (SA) on muscle health. Research has shown that insufficient sleep can harm muscles. Studies have found that lack of sleep reduces the body's ability to build muscle, potentially leading to muscle loss over time. Some research also suggests that sleep deprivation doesn't always significantly affect muscle strength, but the findings are mixed. Overall, adequate sleep appears important for maintaining healthy and strong muscles. Participants in this trial will be assigned to either the SR group, sleeping only 5 hours for three consecutive nights, or the SA group, sleeping for 9 hours for three consecutive nights. ^{2 3 5 6 7}

Who Is on the Research Team?

Lance Bollinger, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

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

You have taken birth control pills in the last three months.

You have been pregnant within the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Unilateral Lower Limb Suspension (ULLS)

Participants undergo 13 days of unilateral lower limb suspension to simulate space flight conditions

13 days

Daily monitoring

Sleep Restriction or Adequate Sleep

Participants are randomly assigned to either restricted sleep (5 hours per night) or adequate sleep (7-9 hours per night) for the final 3 days

3 days

Follow-up

Participants are monitored for changes in balance, muscle strength, and muscle volume using various assessments

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Adequate
• Sleep Restriction

Trial Overview

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.

How Is the Trial Designed?

Group I: Sleep Restriction (SR) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Lance Bollinger

Lead Sponsor

Trials

2

Recruited

30+

National Aeronautics and Space Administration (NASA)

Collaborator

Trials

32

Recruited

1,900+

Published Research Related to This Trial

Patients with neuromuscular disorders experience more severe breathing difficulties during REM sleep compared to when they are awake, highlighting the need for targeted treatment during sleep.

Effective treatment for sleep-disordered breathing in these patients can significantly improve their quality of life and prevent daytime symptoms, necessitating regular monitoring and adjustments based on sleep studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep-disordered Breathing in Neuromuscular Disease. Guilleminault, C., Shergill, RP.[2020]

The study found that older adults with inadequate sleep (less than 6-8 hours or low sleep efficiency) have a significantly higher prevalence of sarcopenia, indicating a strong link between poor sleep quality and muscle loss in aging individuals.

Men showed a higher prevalence of sarcopenia compared to women, suggesting that gender may play a role in how sleep quality affects muscle health in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Sleep Quality on the Prevalence of Sarcopenia in Older Adults: A Systematic Review with Meta-Analysis. Rubio-Arias, JÁ., Rodríguez-Fernández, R., Andreu, L., et al.[2020]

Sarcopenia, a condition characterized by loss of muscle mass and strength in older adults, may be influenced by sleep quality and duration, as sleep disorders can disrupt hormonal pathways that are crucial for muscle maintenance.

Interventions targeting sleep disturbances, such as improving sleep quality and normalizing circadian rhythms, could be a promising new strategy to help preserve or recover muscle health in the elderly, alongside traditional treatments like exercise and nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of sleep on age-related sarcopenia: Possible connections and clinical implications. Piovezan, RD., Abucham, J., Dos Santos, RV., et al.[2015]

In a study of 39 older adults with insomnia, combining sleep restriction therapy with sleep hygiene did not show significant differences in efficacy compared to sleep hygiene alone, suggesting that sleep hygiene may be effective on its own.

The study utilized wrist actigraphy and polysomnography to measure sleep outcomes, finding that actigraphic data correlated well with PSG results, indicating it could be a reliable method for assessing sleep in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An actigraphic comparison of sleep restriction and sleep hygiene treatments for insomnia in older adults. Friedman, L., Benson, K., Noda, A., et al.[2022]

Progressive muscle relaxation (PMR) significantly increased slow-wave sleep (SWS) during a 90-minute nap by about 10 minutes (125% more time) compared to a control group listening to Mozart music, indicating enhanced restorative sleep benefits from PMR.

Participants who practiced PMR also showed greater right lateralized slow-wave and delta activity, suggesting a more recuperative sleep profile, while pre-sleep anxiety levels influenced nap architecture, highlighting the importance of managing anxiety for optimal sleep outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive muscle relaxation increases slow-wave sleep during a daytime nap. Simon, KC., McDevitt, EA., Ragano, R., et al.[2022]

Periodic awakenings during sleep significantly disrupt sleep continuity, leading to a reduction in total sleep time by about 1 hour and severely fragmenting sleep stages, particularly slow-wave and REM sleep.

Following sleep disruption, subjects experienced notable declines in performance and increased sleepiness, comparable to the effects observed after 40-64 hours of total sleep deprivation, highlighting the importance of uninterrupted sleep for cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of sleep disruption on sleep, performance, and mood. Bonnet, MH.[2019]

A 30-minute nap significantly improved reaction times, vigilance, and physical performance in students after both normal sleep and partial sleep deprivation, indicating its effectiveness in enhancing cognitive and physical functions.

Napping also positively influenced mood states, reducing feelings of anxiety, fatigue, confusion, and depression, while increasing vigor, thus helping to counteract the negative effects of sleep deprivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 30 min nap opportunity on cognitive and short-duration high-intensity performances and mood states after a partial sleep deprivation night. Souissi, M., Souissi, Y., Bayoudh, A., et al.[2021]

Lower sleep quality or duration is linked to a higher risk of musculoskeletal injuries (MSI) among military personnel, suggesting that improving sleep could help reduce injury rates.

Strategies to optimize sleep include maintaining a cool sleeping environment, avoiding media devices before bed, and establishing regular sleep schedules, while sleep loss mitigation techniques like napping and sleep banking can also be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep and Injuries in Military Personnel With Suggestions for Improving Sleep and Mitigating Effects of Sleep Loss. Knapik, JJ., Caldwell, JA., Ritland, BM.[2022]

In a study involving 8 sedentary women, partial sleep loss (only 2.5 hours of sleep) did not negatively impact maximal muscle strength or the diurnal variations in muscle strength, suggesting that short-term sleep deprivation may not be as detrimental as previously thought.

Muscle strength measurements showed a significant diurnal variation, with strength being higher in the evening compared to the morning, indicating that the time of day should be carefully controlled in future studies involving female participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of time of day and partial sleep loss on muscle strength in eumenorrheic females. Bambaeichi, E., Reilly, T., Cable, NT., et al.[2005]

Sleep extension has been shown to improve performance and recovery in athletes and military personnel, potentially reducing the risk of muscle injuries by enhancing hormonal responses like GH/IGF-I.

Sleep deprivation negatively impacts muscle tissue and biological responses, while adequate sleep can aid in muscle regeneration and control inflammation, highlighting the need for more research to develop guidelines for optimizing sleep in training and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does sleep help recovery from exercise-induced muscle injuries? Chennaoui, M., Vanneau, T., Trignol, A., et al.[2021]

A 20-minute nap significantly improved sprint performance in highly trained judokas, indicating that short naps can be an effective recovery strategy after partial sleep deprivation.

Combining caffeine with a nap further enhanced performance metrics, but caffeine alone increased muscle damage, suggesting that while caffeine can boost energy, it may not be the best choice for muscle recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caffeine Use or Napping to Enhance Repeated Sprint Performance After Partial Sleep Deprivation: Why Not Both? Romdhani, M., Souissi, N., Moussa-Chamari, I., et al.[2022]

Patients with neuromuscular diseases can experience life-threatening nocturnal respiratory failure, even if their daytime respiratory function appears normal, due to reduced muscle tone during sleep.

Diagnosis of sleep-related breathing issues is best done through polysomnography, and effective treatments like noninvasive ventilation can significantly improve quality of life and potentially increase survival for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nocturnal respiratory failure as an indication of noninvasive ventilation in the patient with neuromuscular disease. Barthlen, GM.[2018]

A study involving 15 resistance-trained males found that a 30 or 60-minute nap after partial sleep restriction did not improve strength performance in exercises like bench press or back squat, but it did enhance cognitive function, particularly in the PSR60 condition.

Participants showed improved mood and alertness after napping, with the best performance in cognitive tasks occurring in the afternoon, suggesting that while naps may not boost physical strength, they can positively affect mental state and cognitive abilities during periods of sleep deprivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is implementing a post-lunch nap beneficial on evening performance, following two nights partial sleep restriction? Gallagher, C., Green, CE., Kenny, ML., et al.[2023]

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Sleep Management for Muscle Weakness

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