sleep extension for Sleep Extension

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Rochester, Rochester, MN
Sleep Extension
sleep extension - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether extending sleep time may help reduce blood pressure in individuals who are currently sleeping less than 7 hours per night.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether sleep extension will improve 1 primary outcome and 3 secondary outcomes in patients with Sleep Extension. Measurement will happen over the course of 8 weeks.

8 weeks
change in 24-hour mean arterial pressure
change in baroreflex sensitivity
change in endothelial function
change in insulin sensitivity

Trial Safety

Trial Design

2 Treatment Groups

sleep maintenance
1 of 2
sleep extension
1 of 2
Active Control
Experimental Treatment

This trial requires 54 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sleep Extension is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

sleep extension
Behavioral
sleep maintenance
Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 8 weeks for reporting.

Who is running the study

Principal Investigator
V. S.
Prof. Virend Somers,, MD PhD
Mayo Clinic

Closest Location

Mayo Clinic in Rochester - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Prehypertension: office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80- 89 mmHg;
Stage 1 hypertension: office SBP 140-159 mmHg and/or DBP 90-99 mmHg
Age: 18 to 65 (inclusive)
Gender: both males and females
Body mass index (BMI): 18.5-34.9 kg/m2
Either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions
Not pregnant or breast feeding and not intending to become pregnant or breast feed
Not a current smoker or tobacco user
Ability to provide written informed consen
Habitual sleep duration: <7 hours

Patient Q&A Section

Can sleep extension be cured?

"A statistically and clinically significant shortening of the mean time to awakening, a marker of sleep disturbance, was observed during the experimental condition with sleep extension using the S-PAP. We consider these findings to be in good agreement with those reported in studies using the S-PAP to reduce arousals or induce sleep. Therefore, we conclude that sleep extension can be a treatment for sleep-disordered breathing, but more extensive studies with longer follow-up are needed." - Anonymous Online Contributor

Unverified Answer

What are the signs of sleep extension?

"Being unable to sleep after a certain period can be a sign of sleep extension. Sleep extension can be difficult to recognize considering that a sleep study can be inconclusive in distinguishing a normal from an abnormal sleep pattern." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sleep extension?

"Common treatments for sleep extension include lifestyle techniques (eg, exercise, sleep restriction), pharmaceutical techniques (eg, melatonin), and complementary treatments (eg, acupuncture). While the evidence supports these interventions for sleep deprivation, evidence is insufficient for their efficacy for sleep extension. Patient and provider preferences, as well as limitations in the treatment of sleep extension may limit the usefulness of these interventions. Future research needs to examine the effectiveness and side effects of treatment for insomnia and sleep extension." - Anonymous Online Contributor

Unverified Answer

Does sleep extension improve quality of life for those with sleep extension?

"Sleep extension appeared to have a significant positive effect on health-related quality of life, but sleep restriction did not. This suggests that sleep extension may be an important determinant of long-term sleep quality. Future intervention studies should address mechanisms of sleep restriction and examine whether sleep restriction leads to other negative health outcomes, like psychological or cardiovascular disease." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of sleep extension?

"Side effects can be classified into four categories: mood changes, sleep disruptions, non-mood-related, and psychiatric-like manifestations. At least one treatment-related adverse effect was detected. Adverse effects are associated with extended doses of night therapy and with increased numbers of patients tested, although not with increased sleep efficiency." - Anonymous Online Contributor

Unverified Answer

Has sleep extension proven to be more effective than a placebo?

"Sleep time extension, using an electronic wrist device, was not more effective than a placebo for the primary outcome of sleep onset latency. Both treatments increased wake time, suggesting a REM rebound was occurring, and sleep quality did not improved." - Anonymous Online Contributor

Unverified Answer

Is sleep extension safe for people?

"Adjuvant sleep extension does not increase sleep duration in healthy young adults. Sleep extension has little effect on vigilance and performance in a simulated operating room task, suggesting that it cannot be used safely to induce sleep." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of sleep extension?

"People who perform more sleep do not have slower heart rates after-hours. Other types of sleep extension were identified, and more rigorous tests are needed for all other types of sleep extension." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving sleep extension?

"Findings from a recent study of this study show that the addition of sleep extension to a patient with moderate insomnia significantly improves sleep efficiency. This finding may prove invaluable in patients with comorbid mood and anxiety disorders and warrants further study." - Anonymous Online Contributor

Unverified Answer

What is sleep extension?

"During the course of an unmeasured night, sleep in the population is characterized by a large component of REM sleep, much larger, however, than the previously reported nightly mean, and a strong and nonuniform influence of naps that were not in the typical pattern of sleep stages. These wakefulness events are associated with significant increases in respiration and alerting response to environmental cues. The current results support the hypothesis that sleep extension affects alertness as a function of sleep respiration and alertness during the period when awakening cues occur." - Anonymous Online Contributor

Unverified Answer

How many people get sleep extension a year in the United States?

"Approximately 70 million people a year will need help in the form of either a sleep extension device or counseling to help them to obtain more uninterrupted sleep." - Anonymous Online Contributor

Unverified Answer

What causes sleep extension?

"Results indicated that two factors, poor sleep duration and poor sleep quality, are positively associated with insomnia. Poor sleep duration and other health, behavioral, and environmental factors can increase the risk of developing sleep disorders, especially insomnia." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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