Trial Outcomes & Findings for A Novel Wearable Device to Improve Sleep Quality (NCT NCT05952297)
NCT ID: NCT05952297
Last Updated: 2025-03-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Change from baseline in insomnia symptoms at 28 days
Results posted on
2025-03-28
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
31
|
|
Overall Study
COMPLETED
|
27
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Novel Wearable Device to Improve Sleep Quality
Baseline characteristics by cohort
| Measure |
Sleep Wellness Device
n=28 Participants
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
|
Inactive Sleep Wellness Device
n=31 Participants
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
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
41.6 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in insomnia symptoms at 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
Sleep Wellness Device
n=25 Participants
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
|
Inactive Sleep Wellness Device
n=29 Participants
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
|
|---|---|---|
|
Insomnia Symptoms
|
-7.34 score on a scale
Standard Deviation 1.87
|
-7.58 score on a scale
Standard Deviation .84
|
Adverse Events
Sleep Wellness Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Inactive Sleep Wellness Device
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sleep Wellness Device
n=28 participants at risk
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
|
Inactive Sleep Wellness Device
n=31 participants at risk
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
|
|---|---|---|
|
General disorders
headache
|
3.6%
1/28 • Number of events 1 • 3 months
Participants reported adverse events to study staff
|
9.7%
3/31 • Number of events 3 • 3 months
Participants reported adverse events to study staff
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place