Treatment for Sleep Debt

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Beth Israel Deaconess Medical Centre, Boston, MA
Sleep Debt+2 More
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a meditation practice can improve sleep quality and cognitive performance.

See full description

Eligible Conditions

  • Sleep Debt
  • Sleep
  • Cognitive Changes

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 3 primary outcomes and 12 secondary outcomes in patients with Sleep Debt. Measurement will happen over the course of change from baseline to 2 months post intervention.

Month 2
Advantageous vs disadvantageous decks - Iowa Gambling Test
Month 2
Error frequency Change: Go-No Go Task
Reaction Time Change: Go-No Go
Month 4
Cognitive Scores change- Well Rested
Correct Word Pairs Change - Word-Pair Memory Consolidation
Error frequency Change: Go-No Go
Reaction time Change- Go-No Go Task
Reaction time Change- Psychomotor Vigilance Task (PVT)
Month 4
Stanford Sleepiness Scale (SSS) change
Month 2
Sleep Architecture change - Time spent in and number of sleep stages
Month 4
Pittsburgh Sleep Quality Index (PSQI) change
Sleep Architecture change - cardiopulmonary coupling variables
Sleep Architecture change- Time spent in and number of sleep stages
Sleep Architecture change- Wake after sleep onset
Sleep Architecture change- delta wave power

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

Shoonya Meditators
1 of 3
Nap Practitioners
1 of 3
Control Meditators
1 of 3
Active Control
Non-Treatment Group

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Nap Practitioners
Behavioral
This is an observational arm of regular nappers. Individuals that take naps at least three times a week will be invited to undergo all of the study procedures for one weekend of data collection.
Control MeditatorsThis is the waitlisted control arm. Participants will practice alternate nostril breathing (sukha kriya) for two months, then will learn shoonya meditation and practice for two months. A weekend of data collection will happen at baseline, two months, and four months.
Shoonya Meditators
Behavioral
This is intervention arm. Participants will learn and practice the fifteen minute shoonya meditation - described as a process of conscious non-doing- and shakti chalana kriya, which is a set of breathing exercises designed as a preparatory practice to shoonya meditation. Participants will practice shoonya meditation twice a day for two months. A weekend of data collection will happen at baseline and two months after they learn the practice.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to 4 months post intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline to 4 months post intervention for reporting.

Who is running the study

Principal Investigator
B. S.
Balachundhar Subramaniam, Principal Investigator
Beth Israel Deaconess Medical Center

Closest Location

Beth Israel Deaconess Medical Centre - Boston, MA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Shoonya meditation program participants/individuals eligible to participate who are healthy adults of age 18 or older, and reside in the United States. Participants must be able and willing to travel to Boston.
Nap Group: Healthy adults of age 18 or older that reside in the United States, nap regularly (at least 3 times a week), and do not meditate regularly.

Patient Q&A Section

What causes sleep debt?

"Sleep debt can be quantified from sleepiness measured objectively using electroencephalography (EEG). A decrease in baseline delta and theta power is associated with sleep debt, and this suggests that the brain cells may be in a state of reduced suppression in sleep debt. Thus sleep debt may be related to a fundamental physiological change rather than just a transient one caused by disruptions of sleep." - Anonymous Online Contributor

Unverified Answer

What are the signs of sleep debt?

"Sleep debt affects the quality of life in people with sleep problems. The symptoms of sleep debt are fatigue, sleepiness or insomnia in the morning, but also worsening in the afternoon. It can be difficult to see the signs of sleep debt for several reasons. Sleep debt is only a symptom of poor quality sleep; it is not a permanent condition. It is possible to reverse this and start recovering by implementing sleep hygiene and by adjusting the sleep environment." - Anonymous Online Contributor

Unverified Answer

Can sleep debt be cured?

"With treatments, sleep debt is a symptom that can be resolved. Sleep debt can be reduced from several months to less than five days with efficient treatment. People can feel as if their lives are back to normal even though their sleep debt has not been fully eliminated." - Anonymous Online Contributor

Unverified Answer

What is sleep debt?

"Sleep debt may be used as an alternative or complementary approach to sleep restriction in patients with chronic insomnia. Future work is needed to examine the effectiveness in clinical practice." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sleep debt?

"Sleep debt was prevalent among adults aged 26–55 years. Sleep debt was associated with poorer self-rated health and socioeconomic status. Sleep debt also predicted higher rates of depression, poorer sleep quality, and lower levels of well-being. Sleep debt in adults should be evaluated in future interventions, and interventions addressing sleep debt should be incorporated into sleep hygiene and sleep deprivation research." - Anonymous Online Contributor

Unverified Answer

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

"Sleep debt is a chronic medical condition that worsens with increasing daytime sleepiness. The number of people affected by this condition in the United States is unclear, but because it is difficult to determine the exact prevalence of sleep debt, the estimate we present is more likely underestimates its true extent. In a recent study, findings has major implications for clinical practice, and identifies sleep debt as an area for future research." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"The most common side effects of treatment and treatment interruption are: rash (4.4%), headache (4%), nausea (3.3%), joint pain (3%), and constipation (1.6%). In total, 32% of healthy subjects reported side effects from treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of sleep debt?

"The correlation between sleep duration and sleep debt is surprising. The primary cause of sleep debt is an excessive number of nocturnal awakenings and insufficient REM sleep. Findings from a recent study have immediate implications for clinicians and patients alike." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"The combination of CBT with other treatments is common across treatment categories (i.e., [adherence], health care team, psychosocial, behavior change). Research is necessary to elucidate factors that influence the type of combinations and how to effectively use these combinations in practice." - Anonymous Online Contributor

Unverified Answer

How serious can sleep debt be?

"In short-stay hospitalizations with a diagnosis of [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) or OSA, we found an association between increased cumulative total sleep time and odds ratios for hospital readmission." - Anonymous Online Contributor

Unverified Answer

What is the latest research for sleep debt?

"The current literature shows that sleep debt is a common phenomenon and affects several aspects of health. It is likely to be underdiagnosed. A more comprehensive questionnaire to assess sleep debt would further support screening. Additional support is needed for more accurate measurement of sleep debt." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"To find the best treatment for patients with insomnia, the number of treatments should be the focus, with a particular focus on combining treatments. Also [dependence] is an important criterion to consider. There are many reasons for a shift from conventional to electronic prescriptions. However, not all changes to electronic prescriptions is really a good idea. The use of an electronic prescription is not a guarantee of treatment success." - 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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