InsomniaPhase 2NCT05952297
A Novel Wearable Device to Improve Sleep Quality
A Phase 2 study testing Sleep Wellness Device (BeCurie) in people with Insomnia, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Sleep Wellness Device (BeCurie)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 17 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically elevated insomnia symptoms as defined by Insomnia Severity Index (ISI) score >=15
- Able to read and write in English
- Smartphone user
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
BeCurie is a wearable sleep wellness device that contains specially designed coils that generate micro electromagnetic stimulation located in the neckband. This device is classified as a low risk wellness device that does not need FDA approval. It can be used by anyone aged 18 and above.
To test the efficacy of this device, a clinical study entitled "Prospective Observational Double-Blind Placebo-Controlled Randomised Clinical Study to Assess the Stress and Anxiety Improvement with BeCurie" was carried out. (CTRI Registration CTRI/2022/03/041445 )Compared to the placebo group, the treatment group showed improvements in all stress and anxiety-related parameters, showing the effectiveness of the BeCurie device in managing stress and anxiety in individuals with perceived stress and anxiety. Further, no changes were observed in blood profile, biochemistry, and physiological parameters in both groups. No adverse events or side effects were recorded during the study in both placebo and treatment arms, demonstrating BeCurie has been well tolerated.
Further testing is warranted to determine whether or not this device has an influence on the quality of sleep of those who wear it. Therefore the goal of this study is to test the effects of this sleep wellness device on sleep quality among adults with elevated insomnia symptoms. This study will test the sleep wellness device compared to a placebo device for changes in sleep over 28 days. Following this 28 day blinded trial, this study will study the effects of the device in an open label, one group study from 28 days to 3 months. This study is fully remote, with no in person office visits. All assessments will occur via web-based surveys, sleep wearable devices (fitbit) and text-message based sleep diaries.
- Conditions
- Insomnia
- Being tested
- Sleep Wellness Device (BeCurie)
- Keywords
- insomnia, sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Wellness Device (BeCurie)Device
This device emits micro electromagnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Sleep Wellness Device | Experimental | The wearable sleep wellness device that contains specially designed coils that generate micro electromagnetic stimulation located in the neckband and is worn around the neck like headphones for at least 3 hours per day. Receives: Device: Sleep Wellness Device (BeCurie) |
| Inactive Sleep Wellness Device | Sham comparator | This sleep wellness device is running an inactive program in the application (no electromagnetic stimulation). Receives: Device: Sleep Wellness Device (BeCurie) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Symptoms
The insomnia severity index (ISI) is a self-report item of insomnia symptoms that is well correlated with insomnia diagnoses, with higher scores being worse insomnia. Scores range from 0-28.
Measured: Change from baseline in insomnia symptoms at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Sep 2023
- Primary completion1 May 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For the first 28 days, participants will be randomized 1:1 to intervention vs. placebo. Following 28 days, all devices will be active from day 28 to 3 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Glazer Baron, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952297
- Sponsor's protocol ID
- 00165943
- Status last verified
- Mar 2025
- First submitted
- 11 Jul 2023
- Last updated
- 28 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anderson DJ, Troxel WM, Landvatter J, Baron KG. A randomized pilot study of a wearable device using variable complex weak magnetic fields among participants with insomnia symptoms. J Clin Sleep Med. 2025 Jul 1;21(7):1285-1291. doi: 10.5664/jcsm.11690.
PubMed 40165746
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Wearable Device to Improve Sleep Quality
- ClinicalTrials.gov ID
- NCT05952297
- Acronym / sponsor ID
- 00165943
- Conditions
- Insomnia
- Keywords
- insomnia, sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BeCurie is a wearable sleep wellness device that contains specially designed coils that generate micro electromagnetic stimulation located in the neckband. This device is classified as a low risk wellness device that does not need FDA approval. It can be used by anyone aged 18 and above.
To test the efficacy of this device, a clinical study entitled "Prospective Observational Double-Blind Placebo-Controlled Randomised Clinical Study to Assess the Stress and Anxiety Improvement with BeCurie" was carried out. (CTRI Registration CTRI/2022/03/041445 )Compared to the placebo group, the treatment group showed improvements in all stress and anxiety-related parameters, showing the effectiveness of the BeCurie device in managing stress and anxiety in individuals with perceived stress and anxiety. Further, no changes were observed in blood profile, biochemistry, and physiological parameters in both groups. No adverse events or side effects were recorded during the study in both placebo and treatment arms, demonstrating BeCurie has been well tolerated.
Further testing is warranted to determine whether or not this device has an influence on the quality of sleep of those who wear it. Therefore the goal of this study is to test the effects of this sleep wellness device on sleep quality among adults with elevated insomnia symptoms. This study will test the sleep wellness device compared to a placebo device for changes in sleep over 28 days. Following this 28 day blinded trial, this study will study the effects of the device in an open label, one group study from 28 days to 3 months. This study is fully remote, with no in person office visits. All assessments will occur via web-based surveys, sleep wearable devices (fitbit) and text-message based sleep diaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- For the first 28 days, participants will be randomized 1:1 to intervention vs. placebo. Following 28 days, all devices will be active from day 28 to 3 months.
| Arm | Type | Receives |
|---|---|---|
| Sleep Wellness Device | Experimental | Device: Sleep Wellness Device (BeCurie)The wearable sleep wellness device that contains specially designed coils that generate micro electromagnetic stimulation located in the neckband and is worn around the neck like headphones for at least 3 hours per day. |
| Inactive Sleep Wellness Device | Sham comparator | Device: Sleep Wellness Device (BeCurie)This sleep wellness device is running an inactive program in the application (no electromagnetic stimulation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically elevated insomnia symptoms as defined by Insomnia Severity Index (ISI) score >=15
- Able to read and write in English
- Smartphone user
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Wellness Device (BeCurie)This device emits micro electromagnetic stimulation | Device | Inactive Sleep Wellness Device, Sleep Wellness Device |
Primary outcome
Insomnia Symptoms
Time frame: Change from baseline in insomnia symptoms at 28 days
The insomnia severity index (ISI) is a self-report item of insomnia symptoms that is well correlated with insomnia diagnoses, with higher scores being worse insomnia. Scores range from 0-28.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40165746Anderson DJ, Troxel WM, Landvatter J, Baron KG. A randomized pilot study of a wearable device using variable complex weak magnetic fields among participants with insomnia symptoms. J Clin Sleep Med. 2025 Jul 1;21(7):1285-1291. doi: 10.5664/jcsm.11690.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sleep Wellness Device (BeCurie) in people with Insomnia, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Symptoms (time frame: Change from baseline in insomnia symptoms at 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05952297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.