A Study of MUSE Device for Midlife Women
The purpose of this study is to see if it is feasible for midlife women to wear a brain activity sensing headband (Muse-S) for management of sleep disturbances such as insomnia and sleep disruption
Conditions:
🦠 Women's Health 🦠 Insomnia 🦠 Sleep Disturbance
🗓️ Study Start (Actual) 1 August 2023
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 45 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 July 2023
  • First Submitted that Met QC Criteria 25 July 2023
  • First Posted 2 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 April 2024
  • Last Update Posted 16 April 2024
  • Last Verified April 2024