Study of the Effects of HIRREM-SOP for Insomnia

NCT ID: NCT03607994

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-19
• Study Completion Date: 2020-07-30

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.

Detailed Description

High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) is a closed-loop, allostatic, acoustic stimulation neurotechnology that uses software-guided algorithmic analysis to identify and translate selected brain frequencies into audible tones to support real-time self-optimization of brain activity. Prior research demonstrates that the use of HIRREM is associated with reduced symptoms of insomnia, and traumatic stress and anxiety, and improved autonomic cardiovascular regulation across heterogeneous cohorts. HIRREM has been safe and well tolerated in about 500 people across six IRB-approved studies. However, the current in-office HIRREM approach remains very operator dependent (extensive Technologist education and experience) and takes a sizeable time commitment from the participant (typically ten or more sessions of 90-120 minutes each). To reduce participant time required, and operator dependence, while increasing scalability, a new generation of hardware and software has been developed. While based on the same core technology and algorithms to mirror brainwaves with audible tones, this includes the use of faster, 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols, all done with eyes closed (HIRREM-SOP). Although only 2 sensors are active at a time, applying 4 sensors, for which the software can switch from one pair to the other automatically, cuts in half the number of sensor placement changes needed, with reduced session time and interruptions. A modified placebo condition now includes random timing and pitch of the tones, which have not been acoustically engineered. This pilot study will evaluate feasibility of this standardized, enhanced approach, and the effectiveness of blinding for the placebo condition in participants with symptoms of insomnia.

Conditions

Insomnia; Sleep Deprivation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

HIRREM-SOP (BCC

Acoustic stimulation linked to brainwave activity and continued current care.

Group Type: ACTIVE_COMPARATOR

HIRREM-SOP

Intervention Type: 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.

nonspecific acoustic stimulation (NCC)

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

Group Type: OTHER

HIRREM-SOP

Intervention Type: 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.

NCC

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

NCC

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles H Tegeler, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Department of Neurology, Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00051980

Identifier Type: -

Identifier Source: org_study_id