Trial Outcomes & Findings for Study of the Effects of HIRREM-SOP for Insomnia (NCT NCT03607994)
NCT ID: NCT03607994
Last Updated: 2022-12-01
Results Overview
The severity of insomnia symptoms is measured using the ISI with each data collection visit. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. Higher scores indicate the strength of the insomnia severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Baseline, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)
Results posted on
2022-12-01
Participant Flow
Participant milestones
| Measure |
HIRREM-SOP (BCC)
Acoustic stimulation linked to brainwave activity and continued current care.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
|
Nonspecific Acoustic Stimulation (NCC)
Continued current care and acoustic stimulation that is not linked to brainwave activity.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
NCC: Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
HIRREM-SOP (BCC)
Acoustic stimulation linked to brainwave activity and continued current care.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
|
Nonspecific Acoustic Stimulation (NCC)
Continued current care and acoustic stimulation that is not linked to brainwave activity.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
NCC: Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity.
|
|---|---|---|
|
Overall Study
Discontinued intervention (started sessions and dropped out due to time commitment and schedule)
|
1
|
1
|
Baseline Characteristics
Study of the Effects of HIRREM-SOP for Insomnia
Baseline characteristics by cohort
| Measure |
HIRREM-SOP (BCC)
n=10 Participants
Acoustic stimulation linked to brainwave activity and continued current care.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
|
Nonspecific Acoustic Stimulation (NCC)
n=12 Participants
Continued current care and acoustic stimulation that is not linked to brainwave activity.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
NCC: Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 Years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
54.67 Years
STANDARD_DEVIATION 19.19 • n=7 Participants
|
56.45 Years
STANDARD_DEVIATION 14.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Insomnia Severity Index (ISI)
|
14.90 units on a scale
STANDARD_DEVIATION 4.65 • n=5 Participants
|
18.00 units on a scale
STANDARD_DEVIATION 3.07 • n=7 Participants
|
16.59 units on a scale
STANDARD_DEVIATION 4.09 • n=5 Participants
|
|
Duration with Sleep Trouble
|
8.98 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
5.28 years
STANDARD_DEVIATION 3.89 • n=7 Participants
|
6.96 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)The severity of insomnia symptoms is measured using the ISI with each data collection visit. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. Higher scores indicate the strength of the insomnia severity.
Outcome measures
| Measure |
HIRREM-SOP (BCC)
n=10 Participants
Acoustic stimulation linked to brainwave activity and continued current care.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
|
Nonspecific Acoustic Stimulation (NCC)
n=12 Participants
Continued current care and acoustic stimulation that is not linked to brainwave activity.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
NCC: Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity.
|
|---|---|---|
|
Change in ISI Score From V1 to V3
|
-7.27 score on a scale
Standard Error 1.55
|
-4.69 score on a scale
Standard Error 1.40
|
SECONDARY outcome
Timeframe: Baseline, before Session 5, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)The participant will indicate which arm of the intervention they believe they are receiving. The effectiveness will be evaluated based on the expectation measure regarding group assignment prior to the 5th session.
Outcome measures
| Measure |
HIRREM-SOP (BCC)
n=10 Participants
Acoustic stimulation linked to brainwave activity and continued current care.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
|
Nonspecific Acoustic Stimulation (NCC)
n=11 Participants
Continued current care and acoustic stimulation that is not linked to brainwave activity.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
NCC: Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity.
|
|---|---|---|
|
Number of Participants That Believe They Are Receiving HIRREM-SOP
Guessed BCC Group (Before Session 5)
|
7 Participants
|
5 Participants
|
|
Number of Participants That Believe They Are Receiving HIRREM-SOP
Guessed NCC Group (Before Session 5)
|
3 Participants
|
6 Participants
|
Adverse Events
HIRREM-SOP (BCC)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nonspecific Acoustic Stimulation (NCC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HIRREM-SOP (BCC)
n=10 participants at risk
Acoustic stimulation linked to brainwave activity and continued current care.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
|
Nonspecific Acoustic Stimulation (NCC)
n=12 participants at risk
Continued current care and acoustic stimulation that is not linked to brainwave activity.
HIRREM-SOP: HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
NCC: Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity.
|
|---|---|---|
|
Nervous system disorders
Other
|
10.0%
1/10 • Number of events 1 • 16-18 weeks after completion of the intervention.
No adverse events or serious adverse events documented during study. Participant ST06 did mention unusual symptoms that was documented, but unsure if study related due to stopping meditation and marijuana use, which were both daily occurrences, as well as a diet change. ST06 reported that she does not feel that the sessions caused her issues.
|
0.00%
0/12 • 16-18 weeks after completion of the intervention.
No adverse events or serious adverse events documented during study. Participant ST06 did mention unusual symptoms that was documented, but unsure if study related due to stopping meditation and marijuana use, which were both daily occurrences, as well as a diet change. ST06 reported that she does not feel that the sessions caused her issues.
|
Additional Information
Catherine Tegeler - Project Manager
Wake Forest Baptist Health
Phone: 336-716-9341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place