IFrom 2011 to 2018, the Brain Body Research Team conducted a series of research projects to evaluate HIRREM in a clinical setting. Summaries of each research study are below.
HIRREM Research
Completed Studies
An open label pilot trial to evaluate the use of HIRREM® as an adjunct for service members or Veterans with military-related symptoms of traumatic stress (NCT03230890).
A randomized clinical trial for patients with Primary Hypertension (high blood pressure with no clearly identified cause), who have blood pressures between 130-159 mmHg systolic, and 80-99 mmHg diastolic. This study compares the use of in-office HIRREM plus continued current care to continued current care alone (NCT03479697).
A randomized clinical trial for women with menopause-related hot flashes, comparing the use of in-office HIRREM plus continued current care to continued current care alone (NCT03512002).
A randomized, placebo controlled clinical trial for those with insomnia (n=107). This study evaluated the use of 10 HIRREM sessions (acoustic stimulation linked to brainwaves), to acoustic stimulation not linked to brainwaves (NCT01971567).
An open-label developmental study that enrolled 300 people to evaluate the feasibility of HIRREM, as well as the effect size and the effect on autonomic function for a variety of symptoms and conditions (NCT02709369).
A randomized, wait-list controlled, pilot clinical trial to study the effect of the addition of HIRREM to usual care in 20 patients with clinical insomnia, as compared to usual care alone. Participants received 8-12 sessions of HIRREM (either immediately or after a slight delay). During the intervention, HIRREM sessions were administered over a 3-week period.
Placebo-controlled trial for episodic migraine (n=33) to evaluate if receiving 6 to 16 HIRREM or sham-placebo sessions over 4 weeks will decrease the number and severity of migraines two months after intervention based on a daily headache diary. Measures were collected at a pre-intervention study visit, and 8-10 weeks after intervention. Those randomized to the placebo group were offered a course of HIRREM following completion of the active phase of the overall study, but no additional measures will be obtained on those subjects.