Stable Sleep Patterns for Sleep Deprivation

Overseen By Joaquin U Gonzales, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Texas Tech University

Must not be taking: Sleep medications, Antihypertensives

Disqualifiers: Obesity, Sleep apnea, Insomnia, Stroke, Coronary heart disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a stable sleep schedule can reduce the negative effects of insufficient sleep on heart and blood vessel health. Participants will either maintain a consistent sleep pattern or continue their usual sleep habits for two weeks. It is ideal for men and women aged 35-64 who are not overweight and do not have sleep disorders such as sleep apnea or insomnia.

As an unphased trial, this study provides a unique opportunity to contribute to understanding the impact of sleep patterns on cardiovascular health.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not take medications that alter sleep or antihypertensive medications.

What prior data suggests that stable sleep patterns are safe for midlife adults?

Research shows that maintaining a regular sleep schedule can improve health. Studies have found that going to bed and waking up at the same time daily can enhance well-being and even lower the risk of early death.

No safety issues are known with maintaining a regular sleep pattern. In fact, getting enough quality sleep is linked to fewer accidents and improved performance in daily activities. Those who follow a consistent sleep schedule are less likely to feel tired or make mistakes during the day.

Overall, a stable sleep routine is safe and beneficial for health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the stable sleep patterns trial because it explores a simple, non-invasive approach to tackling sleep deprivation by emphasizing consistency in sleep schedules. Unlike traditional treatments that often involve medications or supplements aimed at inducing sleep, this method focuses on behavioral adjustments that could lead to more sustainable, long-term benefits. By maintaining a consistent sleep pattern, participants might experience improved sleep quality and overall well-being without the side effects associated with pharmacological options. This trial could offer valuable insights into how regular sleep routines impact health, potentially leading to new recommendations for managing sleep deprivation.

What evidence suggests that stable sleep patterns could be effective for sleep deprivation?

Research has shown that maintaining a regular sleep schedule can significantly impact health. In this trial, participants in the "Stable Sleep" arm will maintain a consistent sleep pattern for two weeks. Studies have found that going to bed and waking up at the same time daily can be a better health indicator than just the total hours of sleep. A consistent sleep routine is linked to improved memory and thinking skills, even with less sleep than desired. For instance, getting at least 7 hours of sleep each night at the same times can enhance memory and focus. Additionally, a regular sleep schedule is associated with a lower risk of early death, suggesting significant benefits for long-term health. ^{2 3 6 7 8}

Who Is on the Research Team?

Joaquin U Gonzales, PhD

Principal Investigator

Texas Tech University

Are You a Good Fit for This Trial?

This trial is for men and women aged 35-64 who are interested in how consistent sleep patterns might affect heart health, even if they don't always get the recommended amount of sleep. Details on other specific inclusion or exclusion criteria were not provided.

Inclusion Criteria

I am between 35 and 64 years old.

I am either a woman or a man.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Informed consent, collection of demographic data, sleep- and health-related surveys, and familiarization with study procedures

1 week

1 visit (in-person)

Habitual Sleep Condition

Participants follow their normal sleep routine for two weeks

2 weeks

1 visit (in-person) before and after sleep deprivation

Stable Sleep Condition

Participants maintain a consistent sleep pattern for two weeks

2 weeks

1 visit (in-person) before and after sleep deprivation

Follow-up

Participants are monitored for changes in vascular function and other health metrics after sleep interventions

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Sleep consistency

Trial Overview The study is looking at whether having a stable sleeping schedule can help protect your blood vessels from damage caused by not getting enough sleep. It's a carefully controlled experiment where participants will have their routines changed to see what happens.

How Is the Trial Designed?

Group I: Stable sleep Experimental Treatment 1 Intervention

Participants will be asked to maintain a consistent sleep pattern for two weeks.

Group II: Habitual Sleep Active Control 1 Intervention

Participants will be asked to maintain their usual sleep pattern for two weeks.

Who Is Running the Clinical Trial?

Texas Tech University

Lead Sponsor

Trials

89

Recruited

10,300+

Published Research Related to This Trial

In a study involving patients with age-related sleep-maintenance insomnia, three melatonin delivery strategies were tested, showing that all treatments significantly reduced the time it took to fall asleep, but did not improve overall sleep quality or duration.

Despite the initial sleep-promoting effects, melatonin did not sustain sleep or enhance subjective sleep quality, indicating that while it can help initiate sleep, it may not be effective for maintaining it in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of melatonin and circadian phase in age-related sleep-maintenance insomnia: assessment in a clinical trial of melatonin replacement. Hughes, RJ., Sack, RL., Lewy, AJ.[2013]

Circadin, a prolonged-release melatonin formulation, effectively improves sleep quality and reduces sleep latency in patients aged 55 and over with primary insomnia, showing benefits in next-day alertness and overall quality of life.

Unlike traditional sedative hypnotics, Circadin does not impair cognitive or psychomotor skills, has no risk of dependence or abuse, and has a favorable safety profile with no significant adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Controlled release melatonin (Circadin) in the treatment of insomnia in older patients: efficacy and safety in patients with history of use and non-use of hypnotic drugs]. Zisapel, N.[2013]

Melatonin is a hormone that helps regulate sleep-wake cycles and has been used to treat various sleep disorders, including jet lag and insomnia.

Prolonged-release melatonin (Circadin) has recently been licensed in the UK specifically for treating primary insomnia, suggesting it may be an effective option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonin for primary insomnia? [2017]

In a study of seven totally blind individuals with free-running circadian rhythms, daily administration of 10 mg of melatonin successfully entrained their rhythms to a normal 24-hour cycle in six out of seven participants.

After achieving entrainment, subjects experienced improved sleep efficiency and reduced wakefulness after sleep onset, and the entrained rhythm persisted even when the melatonin dose was reduced to 0.5 mg per day over three months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Entrainment of free-running circadian rhythms by melatonin in blind people. Sack, RL., Brandes, RW., Kendall, AR., et al.[2022]

Melatonin, particularly in the form of prolonged-release preparations like Circadin®, has been shown to improve sleep quality and reduce sleep latency in older adults, with a well-tolerated dosage of 2 mg once daily over 3 months.

Circadin® does not produce rebound effects or cognitive impairments commonly associated with traditional hypnotics, making it a safer first-line treatment option for insomnia in patients aged 55 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Melatonin: Physiological and pharmacological aspects related to sleep: The interest of a prolonged-release formulation (Circadin®) in insomnia]. Quera-Salva, MA., Claustrat, B.[2019]

Melatonin effectively phase shifts circadian rhythms, making it a useful treatment for sleep disorders related to circadian misalignment, such as jet lag and shift work.

In specific conditions like delayed sleep phase syndrome (DSPS) and non-24-hour sleep-wake disorder, melatonin has been shown to advance sleep onset and improve overall sleep quality compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of melatonin in the treatment of phase shift and sleep disorders. Skene, DJ., Lockley, SW., Arendt, J.[2019]

The novel continuous release and absorption melatonin (CRA-melatonin) maintained plasma levels above the targeted threshold for a median of 6.7 hours, significantly longer than the 3.7 hours for immediate-release melatonin (IR-melatonin), indicating better sustained effects for sleep support.

CRA-melatonin was well-tolerated with no reported adverse events, while IR-melatonin had five treatment-emergent adverse events, suggesting that CRA-melatonin may be a safer option for sleep therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Crossover, Pharmacokinetics Evaluation of a Novel Continuous Release and Absorption Melatonin Formulation. Seiden, DJ., Shah, SM.[2022]

A daily dose of 0.5 mg melatonin effectively entrained the cortisol rhythms in most blind subjects with free-running circadian rhythms, with 7 out of 10 subjects showing positive changes during the treatment period.

Melatonin treatment not only improved sleep duration at night but also reduced daytime napping, suggesting its acute soporific effects may contribute to better sleep quality, especially when administered at the right circadian time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of low-dose 0.5-mg melatonin on the free-running circadian rhythms of blind subjects. Hack, LM., Lockley, SW., Arendt, J., et al.[2022]

Melatonin can effectively improve sleep and adjust circadian rhythms when taken at the right times, helping with issues like jet lag and shift work, but its effectiveness is closely related to the timing and dosage.

While melatonin is generally safe for short-term use in healthy adults, there is a lack of long-term safety data, and its use should be carefully managed to avoid potential negative effects, especially with unregulated preparations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of circadian rhythm disorders--melatonin. Arendt, J., Deacon, S.[2019]

In a study involving 8 healthy male volunteers, melatonin administration (1.5 mg) significantly increased sleep duration by 2 hours during the first 8 hours of a 16-hour sleep opportunity, demonstrating its direct sleep-facilitating effects.

Melatonin treatment enhanced stage 2 sleep and sleep spindle activity while decreasing stage 3 sleep, indicating its role in improving sleep structure without affecting overall sleep duration, supporting its use for circadian-related sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonin advances the circadian timing of EEG sleep and directly facilitates sleep without altering its duration in extended sleep opportunities in humans. Rajaratnam, SM., Middleton, B., Stone, BM., et al.[2018]

Citations

1. nature.com nature.com/articles/s41539-019-0055-z

Sleep quality, duration, and consistency are associated ... Better quality, longer duration, and greater consistency of sleep are strongly associated with better academic performance in college.

2. academic.oup.com academic.oup.com/sleep/article/47/1/zsad253/7280269

Sleep regularity is a stronger predictor of mortality risk than ... Emerging research demonstrates that sleep regularity, the day-to-day consistency of sleep–wake timing, can be a stronger predictor for some health outcomes than ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12116485/

Effects of Sleep Deprivation on Physical and Mental Health ... Adults and the elderly, who often sleep less than 7 h, are at increased risk of health issues ; however, both sleeping too little (less than 6 h) ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352721823002930

The effects of insufficient sleep and adequate sleep on ... Consistent, stable sleep of at least 7 hours/night improves working memory and response inhibition in healthy adults.

5. sleephealthjournal.org sleephealthjournal.org/article/S2352-7218(23)00166-3/fulltext

The importance of sleep regularity: a consensus statement ... Consistency of sleep onset and offset timing is important for health, safety, and performance. Nonetheless, when insufficient sleep is obtained ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK19961/

Extent and Health Consequences of Chronic Sleep Loss and ... Five hours of sleep or less was associated with a 45 percent increase in risk (odds ratio [OR] = 1.45, 95% confidence interval [CI], 1.10–1.92), after adjusting ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/15402002.2025.2522682

Full article: A Mixed-methods Systematic Review of Sleep ... Studies consistently showed that short sleep duration in healthcare workers was associated with worse patient safety (increased errors and poorer cognitive ...

8. mdpi.com mdpi.com/1660-4601/22/4/533

The Interplay Between Sleep and Safety Outcomes in ... Research shows that workers who achieve quality sleep are less likely to experience workplace accidents or injuries, as they are more likely to exhibit safe ...