A Study of MUSE Device for Midlife Women

Overview

About this study

The purpose of this study is to test the feasibility and effectiveness of the Muse-S™ Headband, an electroencephalographic device, in management of sleep disturbances in midlife women.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Women in the menopause transition or in menopause, based on clinical assessment

- PSQI score > 5, with overall sleep quality rating of "fairly bad" or "very bad".

- Motivation VAS score equal to or greater than 5 with overall motivation rating of on a
scale of 0-10 with 0 being not motivated at all and 10 being extremely motivated.

- Access to an iPad, iPhone, or android device.

- Have ability to provide informed consent.

Exclusion Criteria:

- Suspected or confirmed obstructive sleep apnea.

- Moderate to severe vasomotor symptoms warranting prescription medication use. The FDA
categories for hot flash severity are classified as mild (sensation of heat without
sweating), moderate (sensation of heat with sweating, able to continue activity), or
severe (sensation of heat with sweating cause cessation of activity).

- Use of hormone therapy or hypnotic agents.

- Use of supplements known to affect sleep.

- A known, active, untreated clinically significant psychiatric condition.

- Use of an investigational drug within 30 days of study enrollment or presence of a
known history of any condition or factor judged by the investigator to preclude
participation in the study or which might hinder adherence.

- Currently (within the past 3 weeks) been practicing mindfulness training on a
weekly/regular basis.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/8/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Amber Klindworth, P.A.-C.

Open for enrollment

Contact information:

Katie Cruz

(507) 284-5404

Cruz.Katie@mayo.edu

More information

Publications

Publications are currently not available