What side effects are associated with this type of intervention?

Common treatments for improving sleep quality include pharmacologic agents and non-pharmacologic therapies. Pharmacologic treatments, such as sedating medications, can cause side effects like daytime sleepiness, cognitive impairment, and dependency. Non-pharmacologic treatments, including cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy, generally have fewer side effects but may cause mild discomfort or eye strain. Commercially available sleep devices, which monitor and aim to improve sleep patterns, typically have minimal side effects, though their effectiveness can vary based on user adherence and device accuracy.

What prior FDA approvals exist?

FDA-approved treatments for improving sleep quality include prolonged-release melatonin, which has shown significant improvements in sleep quality and morning alertness in older adults. Additionally, oral appliances like mandibular advancement devices are approved for treating obstructive sleep apnea, which can indirectly improve sleep quality. Pharmacologic therapies such as modafinil and armodafinil are approved for managing excessive daytime sleepiness associated with sleep disorders. These treatments focus on enhancing sleep structure and reducing sleep latency, similar to the goals of commercially available sleep devices being studied for monitoring and improving sleep patterns and physiological parameters.

What other types of research exist?

Promising novel alternatives to commercially available sleep devices for 2024 include advanced wearable sensors that monitor circadian rhythms through sweat analysis and portable electronics. These state-of-the-art platforms offer efficient diagnosis and management of chronic conditions by providing detailed insights into sleep patterns and physiological parameters. Additionally, home sleep apnea testing (HSAT) devices validated against standard polysomnography (PSG) are viable for patients at high risk of moderate to severe obstructive sleep apnea, provided there are no significant comorbidities or nonrespiratory sleep disorders.

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Sleep Technology for Improving 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 18-50 years of age

Be between 18 and 65 years old

Must not have

Females who are unable to identify when their monthly menstrual period will occur

Presents with symptoms indicating cardiovascular, pulmonary, renal, or metabolic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monthly from baseline through study completion at 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing gadgets that help cool down the body to see if they can improve sleep quality. The study focuses on adults who have trouble getting good sleep. By lowering the body's core temperature, these devices aim to make it easier to fall asleep and stay asleep.

Who is the study for?

This trial is for men and women aged 18-50 who are interested in how certain devices might improve their sleep and well-being. It's not suitable for those with abnormal sleep schedules, significant upcoming medical changes, or specific health conditions like cardiovascular diseases or diagnosed sleep disorders.

What is being tested?

The study tests the effects of two devices, OOLER and EmbrWave, on participants' sleep quality and overall wellness. The goal is to see if these technologies can enhance recovery from stress and improve performance by affecting nocturnal physiology.

What are the potential side effects?

Since this trial involves commercially available technology designed to augment sleep quality rather than medication, typical drug side effects are not expected. However, discomfort or skin irritation could occur due to device use.

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 50 years old.

Exclusion Criteria

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

Select...

I cannot predict when my menstrual periods will happen.

Select...

I show signs of heart, lung, kidney, or metabolic disease.

Select...

I have been diagnosed with a sleep disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monthly from baseline through study completion at 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monthly from baseline through study completion at 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly from baseline through study completion at 8 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 Eriksen Flanker Task

Change in Nocturnal Heart Rate Variability as measured by OURA Ring

Change in Nocturnal Heart Rate as measured by OURA Ring

+2 more

Secondary study objectives

Change in Subjective Epworth Sleepiness Scale measured via Questionnaire

Changes in Emotional Regulation as measured via ERQ

Changes in Perceived Stress as measured via PSS

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: OOLERActive Control1 Intervention

Participants will use the OOLER device.

Group II: EmbrWaveActive Control1 Intervention

Participants will use the Embr Wave 2 device.

0 / 4Eligibility 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 cognitive-behavioral therapy for insomnia (CBT-I), pharmacological interventions, and the use of commercially available sleep devices. CBT-I works by addressing the thoughts and behaviors that contribute to insomnia, helping patients develop healthier sleep habits. Pharmacological treatments, such as sedative-hypnotics, act on the central nervous system to induce sleep. Commercially available sleep devices, like sleep trackers and smart mattresses, monitor sleep patterns and physiological parameters (e.g., heart rate, breathing) to provide feedback and promote better sleep hygiene. These mechanisms are crucial for sleep quality patients as they offer personalized insights and interventions that can lead to improved sleep patterns, reduced insomnia symptoms, and overall better health and well-being.

Tai Chi Improves Sleep Quality in Healthy Adults and Patients with Chronic Conditions: A Systematic Review and Meta-analysis.Adherence to Technology-Mediated Insomnia Treatment: A Meta-Analysis, Interviews, and Focus Groups.Educational, supportive and behavioural interventions to improve usage of continuous positive airway pressure machines in adults with obstructive sleep apnoea.