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

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Sleep Adequate, Sleep Restriction, Sleep Deprivation, Sleep Loss, Insufficient Sleep, Partial Sleep Restriction for muscle weakness?

Research shows that progressive muscle relaxation, a component of sleep interventions, can increase restorative slow-wave sleep, which is important for recovery and may help with muscle weakness. Additionally, short naps have been found to improve mood and cognitive performance after partial sleep deprivation, suggesting potential benefits for managing muscle weakness. ^{1 2 3 4 5}

Is sleep management generally safe for humans?

Research suggests that sleep management, including sleep restriction and sleep loss, can lead to impaired function and increased risk of muscle injuries, especially when combined with other stressors like high training loads. However, strategies like progressive muscle relaxation can improve sleep quality and may help mitigate some negative effects of sleep loss. ^{1 6 7 8 9}

How does the sleep management treatment for muscle weakness differ from other treatments?

This treatment is unique because it focuses on managing sleep-related breathing issues in patients with muscle weakness, particularly during REM sleep, by providing breathing support tailored to the severity of the problem. Unlike other treatments that may focus on daytime symptoms, this approach emphasizes nighttime monitoring and adjustment to improve overall quality of life. ^{8 10 11 12 13}

Research Team

Lance Bollinger, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

I am between 18 and 50 years old.

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.

I have an irregular heartbeat.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Progressive muscle relaxation increases slow-wave sleep during a daytime nap. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An actigraphic comparison of sleep restriction and sleep hygiene treatments for insomnia in older adults. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Caffeine Use or Napping to Enhance Repeated Sprint Performance After Partial Sleep Deprivation: Why Not Both? [2022]

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Is implementing a post-lunch nap beneficial on evening performance, following two nights partial sleep restriction? [2023]

6. England pubmed.ncbi.nlm.nih.gov

Influence of time of day and partial sleep loss on muscle strength in eumenorrheic females. [2005]

7. Australia pubmed.ncbi.nlm.nih.gov

How does sleep help recovery from exercise-induced muscle injuries? [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Sleep and Injuries in Military Personnel With Suggestions for Improving Sleep and Mitigating Effects of Sleep Loss. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Sleep-disordered Breathing in Neuromuscular Disease. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

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

12. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Sleep Quality on the Prevalence of Sarcopenia in Older Adults: A Systematic Review with Meta-Analysis. [2020]

13. England pubmed.ncbi.nlm.nih.gov

The impact of sleep on age-related sarcopenia: Possible connections and clinical implications. [2015]