Study of the Effects of HIRREM-SOP for Insomnia

NCT03607994 | Completed Results FDA Device

• 1 other identifier: IRB00051980
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia; Sleep Deprivation

Keywords

Neurotechnology; Autonomic Dysregulation; Hyperarousal; Brain Electrical Activity; Closed-loop; Acoustic Stimulation; Allostasis; Insomnia; HIRREM-SOP; Sleep Deprivation

Outcome Measures

Primary Outcomes (1)

• Change in ISI Score From V1 to V3

  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.

  Baseline, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)

Secondary Outcomes (1)

• Number of Participants That Believe They Are Receiving HIRREM-SOP

  Baseline, before Session 5, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)

Study Arms (2)

HIRREM-SOP (BCC

ACTIVE COMPARATOR

Acoustic stimulation linked to brainwave activity and continued current care.

Device: HIRREM-SOP

nonspecific acoustic stimulation (NCC)

OTHER

Continued current care and acoustic stimulation that is not linked to brainwave activity.

Device: HIRREM-SOP; Device: NCC

Interventions

HIRREM-SOP DEVICE

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.

HIRREM-SOP (BCC; nonspecific acoustic stimulation (NCC)

NCC DEVICE

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

nonspecific acoustic stimulation (NCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical Insomnia (Insomnia Severity Index ≥ 8) persisting by self-report for at least a month
• Subjects must have the ability to comply with basic instructions and be able to comfortably sit still with the sensor leads attached

You may not qualify if:

• Unable, unwilling, or incompetent to provide informed consent
• Physically unable to come to the study visits, or to sit in a chair for several hours
• Known seizure disorder
• Known obstructive sleep apnea
• Diagnosed periodic limb movement disorder or known restless legs syndrome
• Known urinary problem (i.e. benign prostatic hypertrophy) which is the likely cause of the sleep disturbance
• Severe hearing impairment (because the subject will be using ear buds during HIRREM-SOP)
• Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications (SSRI, or SNRI's), sleep medications such as zolpidem or eszopiclone, stimulants such as Adderall, Provigil, or Ritalin, or thyroid hormone
• Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
• Weight is over the chair limit (285 pounds)
• Currently in another active intervention research study
• Previous history of receiving or using HIRREM, BWO, HIRREM-SOP, or the wearable B2

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Department of Neurology, Wake Forest School of Medicine

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Deprivation; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases

Limitations and Caveats

As a pilot study, small sample size was the key limiting factor.

Results Point of Contact

• Title: Catherine Tegeler - Project Manager
• Organization: Wake Forest Baptist Health

categele@wakehealth.edu

336-716-9341

Study Officials

• Charles H Tegeler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will compare acoustic stimulation linked to brainwave activity (HIRREM-SOP, along with continued current care, BCC) with acoustic stimulation not linked to brainwave activity (NCC, along with continued current care). The participants in the NCC group with will offered the opportunity to crossover and receive a course of BCC at the end of their original participation.

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 31, 2018
• Study Start: November 19, 2018
• Primary Completion: March 5, 2020
• Study Completion: July 30, 2020
• Last Updated: December 1, 2022
• Results First Posted: June 22, 2021

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)