CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
HIRREM-SOP +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03607994
NCT03607994N/ACompleted

Randomized Controlled Pilot Trial of HIRREM-SOP for Insomnia

Wake Forest University Health Sciences·interventional·Posted Jul 31, 2018·Updated Dec 1, 2022

In Brief

A clinical study evaluating HIRREM-SOP and NCC for Insomnia and Sleep Deprivation. Completed, enrolled 22 participants across 1 site.

Detailed Summary

Prior research studies have shown benefit for use of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), to reduce symptoms of moderate to severe insomnia. HIRREM uses scalp sensors to monitor brain electrical activity, and software algorithms translate selected brain frequencies into audible tones in real time. Those tones (acoustic stimulation) are reflected back to participants via ear buds in as little as four milliseconds, providing the brain an opportunity to self-adjust and balance its electrical pattern. The purpose of this research study is to determine the effects of HIRREM-SOP, an updated version of this technology that is based on the HIRREM approach, but now includes new hardware and software, a standardized series of HIRREM protocols, and a fixed number of sessions. Adults over the age of 18 who have documented sleep trouble that place them in the category of subthreshold (mild), moderate, or severe clinical insomnia as defined by the Insomnia Severity Index, are eligible to participate in the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 31, 2018
Enrollment StartNov 19, 2018
Primary CompletionMar 5, 2020
Study CompletionJul 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.9 years ago

Interventions

HIRREM-SOPdevice

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.

NCCdevice

Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity.