Insomnia
Conditions
Keywords
insomnia, sleep
Brief 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.
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.
Interventions
DEVICESleep Wellness Device (BeCurie)
This device emits micro electromagnetic stimulation
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Devices will appear the same but some devices will be placebo and some will be turned on as active. This is turned on remotely. A staff member who is blinded to the study screening and outcomes will conduct the randomization allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Symptoms | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sleep Wellness Device 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.
Sleep Wellness Device (BeCurie): This device emits micro electromagnetic stimulation | 28 |
| Inactive Sleep Wellness Device This sleep wellness device is running an inactive program in the application (no electromagnetic stimulation).
Sleep Wellness Device (BeCurie): This device emits micro electromagnetic stimulation | 31 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Inactive Sleep Wellness Device | Total | Sleep Wellness Device |
|---|---|---|---|
| Age, Continuous | 41.6 years STANDARD_DEVIATION 11.8 | 40.4 years STANDARD_DEVIATION 12.1 | 38.9 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 54 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 42 Participants | 20 Participants |
| Sex: Female, Male Female | 20 Participants | 39 Participants | 19 Participants |
| Sex: Female, Male Male | 11 Participants | 20 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 31 |
| other Total, other adverse events | 1 / 28 | 3 / 31 |
| serious Total, serious adverse events | 0 / 28 | 0 / 31 |
Outcome results
Primary
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.
Time frame: Change from baseline in insomnia symptoms at 28 days
Population: Data missing for 2 participants in the control group at 1 month. Data missing for 3 intervention participants at 1 month due to loss to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Wellness Device | Insomnia Symptoms | -7.34 score on a scale | Standard Deviation 1.87 |
| Inactive Sleep Wellness Device | Insomnia Symptoms | -7.58 score on a scale | Standard Deviation 0.84 |
p-value: 0.88mixed model