Trial Summary
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.
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.12345
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.24678
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.146910
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
Treatment Details
Interventions
- Sleep consistency (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Texas Tech University
Lead Sponsor