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NCT01971567 · ClinicalTrials.gov registry record · NA

High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia

A NA study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
NA
Development phase
107
Enrollment target

NCT01971567: Completed NA study, sponsored by Wake Forest University Health Sciences.

NCT01971567 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 107 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01971567, a NA study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
NA
Development phase
107 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether the addition of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) to usual care will improve insomnia symptoms based on changes in the Insomnia Severity Index at two months following completion of the intervention, compared to placebo plus usual care.

Primary Outcome

The ISI is a 7 question, self-reported measure to evaluate symptoms of insomnia, with responses from 0-4 for each question, yielding scores ranging from 0-28. Lower scores represent better outcomes. The primary outcome will be change from enrollment to 8-10 weeks after completion of the intervention.

Interventions

  • DEVICE HIRREM

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2013-10
Est. Completion 2017-02-06
Phase NA
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT01971567 record still lists

NCT01971567 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which HIRREM is the first listed.

NCT01971567 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01971567 about?

NCT01971567 is a clinical study titled "High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia". The purpose of this study is to determine whether the addition of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) to usual care will improve insomnia symptoms based on changes in the Insomnia Severity Index at two months following completion of the intervention, co...

What is the current status of trial NCT01971567?

This trial is currently completed. It is a NA study. The enrollment target is 107 participants. The study started on 2013-10. Estimated completion is 2017-02-06.

What interventions are being tested in trial NCT01971567?

The interventions under investigation include: HIRREM (DEVICE).

Who is sponsoring clinical trial NCT01971567?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01971567's enrollment target sits among peer trials

107 830th of 2000 higher than 1,171 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01971567, the US trial registry maintained by the National Library of Medicine. NCT01971567 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.