Trials / Completed
CompletedNCT03512002
HIRREM Hot Flashes Study
High-Resolution, Relational, Resonance-Based, Electroencephalic Mirroring (HIRREM) for Vasomotor Symptoms (Hot Flashes) in Perimenopausal and Postmenopausal Women: A Randomized, Controlled Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- Female
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to determine the effects of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for women in any stage of menopause, who are experiencing menopause-related hot flashes.
Detailed description
The purpose of this research study is to determine the effects of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for hot flashes. HIRREM uses scalp sensors to monitor brain electrical activity, and computer software algorithms translate selected brain frequencies into audible tones in real time. Those tones are reflected back to participants via ear buds in as little as four to eight milliseconds, providing the brain an opportunity for self-adjustment of its electrical pattern. This study will compare acoustic stimulation linked to brainwave activity (HIRREM, along with continued current care, HCC), with continued current clinical care alone (CCC). Both groups will continue their other current care throughout, including non-pharmacological, and lifestyle modification therapies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HIRREM | Technology |
| OTHER | Continued Current Care | Continue their current clinical care. |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2020-05-27
- Completion
- 2020-05-27
- First posted
- 2018-04-30
- Last updated
- 2023-05-23
- Results posted
- 2023-05-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03512002. Inclusion in this directory is not an endorsement.