What side effects are associated with this type of intervention?

Common treatments for improving sleep quality include cognitive behavioral therapy (CBT), pharmacotherapy, and non-pharmacological interventions like Tai Chi. CBT is generally safe with minimal side effects, though some individuals may experience temporary increases in anxiety or stress. Pharmacotherapy, including medications like ramelteon and off-label sedating antidepressants, can cause side effects such as daytime sleepiness, dizziness, and potential dependency. Non-pharmacological interventions like Tai Chi are typically well-tolerated, with the most common side effects being mild muscle soreness or fatigue.

What prior FDA approvals exist?

FDA-approved treatments for improving sleep quality include a range of pharmacological options such as benzodiazepines (e.g., temazepam), non-benzodiazepine sleep aids (e.g., zolpidem), melatonin receptor agonists (e.g., ramelteon), and orexin receptor antagonists (e.g., suvorexant). Non-pharmacological interventions, such as cognitive-behavioral therapy for insomnia (CBT-I), are also recognized for their efficacy in enhancing sleep quality. These treatments align with the goals of augmented recovery strategies by addressing both the physiological and psychological aspects of sleep disturbances.

What other types of research exist?

Promising novel alternatives for enhancing sleep quality in 2024 include: 1) Mobile texting recovery support and smartphone applications for ongoing sleep management and support. 2) Synchronous, virtually delivered cognitive behavioral therapy for insomnia (CBT-I), particularly targeted at specific populations like cancer survivors. 3) Transdiagnostic sleep and circadian interventions augmented by text messaging to reinforce treatment information and improve adherence. These strategies leverage technology to provide continuous support and personalized interventions, showing potential for improved sleep outcomes.

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Behavioural Intervention

Float Therapy for Sleep Quality

N/A

Waitlist Available

Research Sponsored by West Virginia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female 18-60 years of age

Be between 18 and 65 years old

Must not have

Has an injury requiring an orthopedic cast (i.e. plaster or synthetic), immovable splint or brace

Has skin ulcers, open rashes, incisions, stitches or large open wounds that could cause pain when exposed to saltwater

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1, week 5, and week 9

Awards & highlights

No Placebo-Only Group

Summary

This trial compares traditional flotation therapy and Zerobody Dry Float technology to see how they affect sleep quality and stress levels in people with poor sleep and high stress. Flotation-REST is a treatment for deep relaxation, where a person is contained in a stimuli-restricted environment and floats in water with high salt content.

Who is the study for?

This trial is for men and women aged 18-60 who want to improve their sleep quality. It's not suitable for individuals taller than 76 inches, those with recent piercings or tattoos, a history of loss of consciousness or brain injury, skin conditions, certain medical devices, seizures in the last decade, weight over 250 pounds, motion sickness, communicable diseases or psychiatric conditions.

What is being tested?

The study compares two types of floatation therapy: Traditional Float-REST Therapy where participants float in saltwater tanks and Simulated Flotation Therapy that mimics this experience without water. The goal is to see which method better enhances sleep and overall well-being.

What are the potential side effects?

While flotation therapy is generally safe and relaxing, some may experience side effects such as discomfort from the high salt content if they have open wounds or skin sensitivity. Claustrophobia could be triggered due to the confined space of the tanks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently wearing a cast, splint, or brace that cannot be moved.

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I have open wounds or skin issues that saltwater could irritate.

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I have had a seizure within the last 10 years.

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I do not have any communicable diseases like HIV or Hepatitis.

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I have participated in a float-REST session within the last 3 months.

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I cannot control my bodily functions.

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I have been diagnosed with a psychiatric condition like schizophrenia or bipolar disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 times a week, in 3 week increments, through study completion at 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 times a week, in 3 week increments, through study completion at 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 times a week, in 3 week increments, through study completion at 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in daily self-report measures for recovery

Change in daily self-report measures for task load

Change in daily self-report measures in perceived exertion

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Simulated Flotation TherapyExperimental Treatment1 Intervention

Participants will utilize the Zerobody dry flotation therapy.

Group II: Traditional Float-REST TherapyActive Control1 Intervention

Participants will utilize sensory deprivation tanks.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for improving sleep quality include pharmacological options like melatonin, which helps regulate the sleep-wake cycle, and sedative-hypnotics that enhance GABA activity to induce sleep. Non-pharmacological treatments such as cognitive behavioral therapy for insomnia (CBT-I) address maladaptive thoughts and behaviors, while relaxation techniques like Tai Chi reduce stress and promote relaxation. These treatments are essential for sleep quality patients as they address the root causes of sleep disturbances, leading to better sleep and overall health.

The effect of acceptance and commitment therapy on insomnia and sleep quality: A systematic review.Non-Pharmacological Interventions to Improve Chronic Disease Risk Factors and Sleep in Shift Workers: A Systematic Review and Meta-Analysis.Tai Chi Improves Sleep Quality in Healthy Adults and Patients with Chronic Conditions: A Systematic Review and Meta-analysis.