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MenoSleepHRV Version 3.0

  • Research type

    Research Study

  • Full title

    Observational Feasibility Study: Measuring changes in sleep and heart rate variability in perimenopause and menopause prior to and during hormone replacement therapy using the Oura Ring

  • IRAS ID

    307237

  • Contact name

    Stuart Stewart

  • Contact email

    stuart.stewart@nhs.net

  • Sponsor organisation

    Newson Health Research and Education Ltd.

  • Duration of Study in the UK

    0 years, 11 months, 31 days

  • Research summary

    The aim of this research is to understand how hormone replacement therapy (HRT) affects a woman’s sleep and heart rate when she is experiencing symptoms of perimenopause or menopause. This study will do this by continually monitoring a woman’s sleep and heart rate using a wearable (non-medical) device called an Oura Ring which is a ring-sized rechargeable plastic and metal ring worn on a finger or thumb which is Bluetooth-linked to a smartphone with an associated installed app. She will be invited to wear this ring for 2 months before she starts using hormone replacement therapy, and for 6 months during the use of hormone replacement therapy. During this time, she will also be invited to fill out questionnaires associated with her symptoms and her treatment.

    We plan to recruit up to 500 women who are currently on the waiting list for an appointment with the Newson Health Menopause Clinic. We will purposively sample women to ensure a broad diversity of age and ethnic background. Only women with medical conditions, jobs, or medications that would clearly alter their sleep patterns or heart rate (for example, an irregular heartbeat) would be excluded from this study. Women will also need to have a smartphone on which they can install the Oura app.

    Through this study, we hope to inform doctors, the government, and members of the public about how treatment with hormone replacement therapy affects a woman’s sleep and heart rate, both of which are associated with health and wellbeing.

  • REC name

    North West - Greater Manchester Central Research Ethics Committee

  • REC reference

    22/NW/0089

  • Date of REC Opinion

    21 Apr 2022

  • REC opinion

    Favourable Opinion