InsomniaNCT03607994
Study of the Effects of HIRREM-SOP for Insomnia
A study testing HIRREM-SOP and NCC in people with Insomnia and Sleep Deprivation, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Sleep Deprivation
- What is being tested?
- HIRREM-SOP and NCC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Neurology, Wake Forest School of Medicine
Winston-Salem, North Carolina, 27104
About this study
Official title: 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.
Read the 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
- Being tested
- HIRREM-SOP, NCC
- Keywords
- Neurotechnology, Autonomic Dysregulation, Hyperarousal, Brain Electrical Activity, Closed-loop, Acoustic Stimulation, Allostasis, Insomnia, HIRREM-SOP, Sleep Deprivation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Deprivation, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| HIRREM-SOP (BCC | Active comparator | Acoustic stimulation linked to brainwave activity and continued current care. Receives: Device: HIRREM-SOP |
| nonspecific acoustic stimulation (NCC) | Other | Continued current care and acoustic stimulation that is not linked to brainwave activity. Receives: Device: HIRREM-SOP; Device: NCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The participant will indicate which arm of the intervention they believe they are receiving. The effectiveness will be evaluated based on the expectation measure regarding group assignment prior to the 5th session.
Measured: Baseline, before Session 5, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start19 Nov 2018
- Primary completion5 Mar 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles H Tegeler, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607994
- Sponsor's protocol ID
- IRB00051980
- Status last verified
- May 2022
- First submitted
- 13 Jul 2018
- Last updated
- 1 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Trial of HIRREM-SOP for Insomnia
- ClinicalTrials.gov ID
- NCT03607994
- Acronym / sponsor ID
- IRB00051980
- Conditions
- Insomnia, Sleep Deprivation
- Keywords
- Neurotechnology, Autonomic Dysregulation, Hyperarousal, Brain Electrical Activity, Closed-loop, Acoustic Stimulation, Allostasis, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Posted 22 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| HIRREM-SOP (BCC | Active comparator | Device: HIRREM-SOPAcoustic stimulation linked to brainwave activity and continued current care. |
| nonspecific acoustic stimulation (NCC) | Other | Device: HIRREM-SOP, Device: NCCContinued current care and acoustic stimulation that is not linked to brainwave activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIRREM-SOPHIRREM-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. | Device | HIRREM-SOP (BCC, nonspecific acoustic stimulation (NCC) |
| NCCNonspecific acoustic stimulation with randomly generated tones not linked to brain activity. | Device | nonspecific acoustic stimulation (NCC) |
Primary outcome
Change in ISI Score From V1 to V3
Time frame: Baseline, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)
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.
1 secondary outcome
Number of Participants That Believe They Are Receiving HIRREM-SOP
Time frame: Baseline, before Session 5, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles H Tegeler, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIRREM-SOP and NCC in people with Insomnia and Sleep Deprivation, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ISI Score From V1 to V3 (time frame: Baseline, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.