Study of the Effects of HIRREM-SOP for Insomnia
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2018 |
| Start Date: | November 19, 2018 |
| End Date: | November 2019 |
| Contact: | Study Coordinator |
| Email: | wfhirrem@wakehealth.edu |
| Phone: | 336-716-9447 |
Randomized Controlled Pilot Trial of HIRREM-SOP for Insomnia
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.
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.
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.
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.
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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Principal Investigator: Charles H Tegeler, MD
Phone: 336-716-9447
Click here to add this to my saved trials
