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

16 Participants Needed

Trial Summary

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 data supports the idea that Stable Sleep Patterns for Sleep Deprivation is an effective treatment?

The available research shows that melatonin, a key component of Stable Sleep Patterns for Sleep Deprivation, can help improve sleep in various conditions. For instance, it has been effective in treating sleep disorders like delayed sleep phase syndrome and non-24-hour sleep-wake disorder, especially in blind individuals. In older patients with insomnia, melatonin improved sleep quality and next-day alertness without causing dependency or significant side effects. Compared to traditional sleep medications, melatonin does not impair cognitive skills or have a high risk of abuse, making it a safer alternative. ^{1 2 3 4 5}

What safety data exists for melatonin treatments?

Melatonin treatments, including formulations like Circadin, have been shown to be safe in short-term use for treating sleep disorders such as primary insomnia. Clinical trials indicate no significant adverse events compared to placebo, and no evidence of cognitive or psychomotor impairment, rebound, dependence, or abuse potential. However, while short-term studies show low toxicity, there is a lack of long-term safety data. Melatonin can be used with most medications but may enhance the effects of GABA-A receptor modulators. The safety of over-the-counter preparations and effects during pregnancy remain unaddressed. ^{2 4 6 7 8}

Is the drug used in the trial 'Stable Sleep Patterns for Sleep Deprivation' a promising treatment?

Yes, the drug melatonin is a promising treatment for sleep disorders. It helps regulate sleep patterns by adjusting the body's internal clock, improving sleep quality, and reducing the time it takes to fall asleep. It is especially useful for conditions like insomnia and circadian rhythm disorders. ^{1 4 6 9 10}

What is the purpose of this trial?

Sleep is now recognized as important for disease prevention. Too little or too much sleep contributes to cardiovascular disease. Leading health organizations recommend adults sleep 7-9 hours per night for optimal health. This recommendation is based on research that finds reductions in sleep duration elevate blood pressure and impair vasodilation of blood vessels. One question raised in a recent NIH Workshop report (PMID:36448463) is whether stable sleep patterns, irrespective of a person's sleep duration, could mitigate the adverse effects of insufficient sleep on vascular function. This project will address this question in midlife adults using a randomized, crossover designed study.

Research Team

Joaquin U Gonzales, PhD

Principal Investigator

Texas Tech University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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]

References

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

Use of melatonin in the treatment of phase shift and sleep disorders. [2019]

2. Israel 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]. [2013]

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

Entrainment of free-running circadian rhythms by melatonin in blind people. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Melatonin for primary insomnia? [2017]

5. United States 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. [2013]

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

The effects of low-dose 0.5-mg melatonin on the free-running circadian rhythms of blind subjects. [2022]

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

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

8. England pubmed.ncbi.nlm.nih.gov

Treatment of circadian rhythm disorders--melatonin. [2019]

9. England 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. [2018]

10. France pubmed.ncbi.nlm.nih.gov

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