Phase 2
N=59
A Novel Wearable Device to Improve Sleep Quality
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT05952297 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Insomnia Symptoms — -7.34; -7.58 score on a scale — p=.88
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sleep Wellness Device (BeCurie) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Symptoms |
-7.34; -7.58 | .88 |
Summary
The purpose of the study is to help determine if a wearable sleep wellness device improves sleep among adults with insomnia. This study will enroll a total of 60 participants for this remotly conducted study and randomize 1:1 for treatment and control.
Aim 1 of the study is to test the effects of the sleep wellness device compared to a placebo device on sleep after 28 days of use.
Aim 2 of the study is to test the longer term effects of the sleep wellness device at 3 month follow-up.
Eligibility Criteria
Inclusion Criteria
- Clinically elevated insomnia symptoms as defined by Insomnia Severity Index (ISI) score >=15
- Able to read and write in English
- Smartphone user
Exclusion criteria
- History of chronic drug or alcohol abuse
- More than 400mg of caffeine per day
- Consistent travel across time zones throughout the study period
- Consistent migraine attacks or headaches
- Diagnosed sleep disorders other than insomnia
- Prescribed sleep medications or other treatments for insomnia (e.g. cognitive behavioral therapy)
- Untreated or unstable psychiatric disorders as defined by a PHQ8 score of greater than 15
- Using antipsychotic drugs
- Pregnant women or lactating women, or have an infant less than 6 months old
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- A history of serious medical conditions (e.g. cancers, consistent hospitalizations)
- History of allergy or hypersensitivity to any medical device or its components
- Overnight work >1 shift per month
Data sourced from ClinicalTrials.gov (NCT05952297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.