Clinical trial NCT03607994: Study of the Effects of HIRREM-SOP for Insomnia
Official title: Randomized Controlled Pilot Trial of HIRREM-SOP for Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep Deprivation
Keywords: Neurotechnology
Autonomic Dysregulation
Hyperarousal
Brain Electrical Activity
Closed-loop
Acoustic Stimulation
Allostasis
Insomnia
HIRREM-SOP
Sleep Deprivation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in ISI Score From V1 to V3
timeFrame: Baseline, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)
Secondary outcomes:
measure: Number of Participants That Believe They Are Receiving HIRREM-SOP
timeFrame: Baseline, before Session 5, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Department of Neurology, Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles H Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
References: