100 Participants NeededMy employer runs this trial

Eight Sleep Pod System for Insomnia

AM
MH
Overseen ByMegan Holm, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if the Eight Sleep Pod, a device that regulates bed temperature overnight, can improve health aspects such as gut health, inflammation, and daily body rhythms in individuals with sleep issues. Participants will use the device for two weeks and then not use it for another two weeks. The trial seeks postmenopausal women and men of similar age who have sleep difficulties and reside near Boston. Participants should not have prior experience with the Eight Sleep Pod and must be willing to provide several health samples during the study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance sleep quality and overall health.

Do I need to stop my current medications for the trial?

Participants must have a stable medication regimen, meaning no changes in medication type or dose within 3 months before the study starts and no plans to change during the study. This includes long-term medications like antidepressants, statins, hormones, antihypertensives, or levothyroxine.

What prior data suggests that the Eight Sleep Pod System is safe for use in this study?

Research shows that the Eight Sleep Pod System, which controls temperature during sleep, is generally well-received by users. Studies have found that this system can reduce nighttime hot flashes by an average of 56%, particularly in women experiencing menopause. This suggests it might improve sleep without causing major side effects. The available data reports no serious problems, indicating it is safe to use. However, as with any new treatment, individual experiences may vary.12345

Why are researchers excited about this trial?

The Eight Sleep Pod System is unique because it uses active temperature regulation to address insomnia, a novel approach compared to traditional methods like medication or cognitive behavioral therapy. Unlike standard treatments that often involve altering brain chemistry or sleep habits, this system targets the body's temperature, which plays a crucial role in sleep quality. Researchers are excited about this treatment because it offers a non-invasive, drug-free alternative that could potentially improve sleep by optimizing the sleep environment.

What evidence suggests that the Eight Sleep Pod System is effective for insomnia?

Research has shown that the Eight Sleep Pod System can greatly improve sleep quality. One study found that this temperature-controlling mattress cover helped people fall asleep 44% faster and increased deep sleep by 34%. Another study noted a 32% average improvement in overall sleep quality. Users with sleep problems reported a 23% drop in disturbances, likely due to the system's effective temperature control. In this trial, participants will experience the Eight Sleep Pod System with active temperature regulation turned on and then off to evaluate its impact on insomnia. These findings suggest that the Eight Sleep Pod System could help improve sleep for people with insomnia.23678

Who Is on the Research Team?

DH

David He, PhD

Principal Investigator

Vice President of Research and Development,

Are You a Good Fit for This Trial?

This trial is for postmenopausal women and men of similar age who report having trouble sleeping. Participants should not have conditions or use medications that could interfere with the study, as determined by the researchers.

Inclusion Criteria

All Cohorts: Self-reported poor sleep quality with PSQI score greater than 5
All Cohorts: Weight ≥ 88 lbs
All Cohorts: No MRI scheduled during study period or within 1 week after study conclusion
See 24 more

Exclusion Criteria

I have been diagnosed with abnormal testosterone levels.
I have not changed my use of supplements or probiotics in the last 3 months.
I am currently taking antibiotics or started/stopped them in the last 3 months.
See 36 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Preparatory Period

Baseline assessments including PSQI, WHO-5, MRS, PROMIS, and FACIT-Fatigue are conducted

1 week

Treatment: ATR ON

Participants use the Eight Sleep Pod with temperature regulation ON for 2 weeks

2 weeks
Continuous monitoring with sleep tracking devices

Washout

A 3-day period without any intervention to eliminate carryover effects

3 days

Treatment: ATR OFF

Participants use the Eight Sleep Pod with temperature regulation OFF for 2 weeks

2 weeks
Continuous monitoring with sleep tracking devices

Follow-up

Participants are monitored for changes in gut microbiome, inflammation, and circadian rhythm

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Overnight Active Temperature Regulation: Eight Sleep Pod System

Trial Overview

The study tests if using an overnight temperature-regulating mattress (Eight Sleep Pod) for two weeks can improve gut health, reduce inflammation, and help regulate daily body rhythms in people with poor sleep.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Overnight Active Temperature Regulation ON and then OFFExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eight Sleep Inc.

Lead Sponsor

Boston University

Collaborator

Trials
494
Recruited
9,998,000+

Citations

Sleeping for One Week on a Temperature-Controlled Mattress ...

The median Pod temperatures during Pod ON for women vs. men at Bedtime were 25.8 °C vs. 23.4 °C, respectively; for the Early Phase, were 26.0 °C vs. 25.4 °C, ...

What Is an Eight Sleep Mattress and How Does It Improve ...

A 2024 peer-reviewed study found that sleeping on a temperature-controlled mattress cover for one week improved sleep and cardiovascular ...

Eight Sleep Pod 6 | Intelligent Bed Cooling & Heating

Fall asleep faster. Up to 44% less time to fall asleep ; Sleep deeper. Up to 34% more deep sleep ; Get higher quality sleep. 32% average increase in sleep quality ...

Eight Sleep Pod leads to improved sleep quality

Members reported that sleeping on the Pod reduced their sleep disturbances by 23%. This improvement is likely due to the temperature regulation ...

BTS: How Eight Sleep ran one of the most comprehensive ...

Results reported are based on the average reduction in hot flashes seen in an Eight Sleep clinical study (n=98) evaluating menopausal women ...

Eight Sleep Pod 6 | Intelligent Bed Cooling & Heating

Fall asleep faster and stay asleep longer with personalized cooling and heating for each side of the bed. Pod 6 reduces snoring and works with any mattress.

BTS: How Eight Sleep ran one of the most comprehensive ...

This paper examines how sleeping on the Pod reduces nighttime hot flashes by 56% on average and improves perceived sleep quality in menopausal ...

1 Year Eight Sleep Review What They're Not Telling You

Spoiler alert: It's really good but not perfect. Just sleep in a cool room (via AC), don't eat a big meal before bed, sleep in total darkness ...