Putting Theory into Practice by Developing a Novel Digital Health Technology-Derived Endpoint in Sleep Quality.

Area of Science:

• Digital Health Technologies
• Menopause Research
• Sleep Science

Background:

• Sleep disturbances associated with menopause (SDM) are prevalent and lack specific approved treatments.
• Current sleep quality assessments vary in methodology, hindering consistent clinical trial outcomes.
• Digital health technologies (DHTs) offer a promising avenue for objective, patient-centric sleep monitoring in real-world settings.

Purpose of the Study:

• To collaboratively develop and validate a novel digital health technology (DHT)-derived endpoint for assessing sleep quality in menopausal women.
• To demonstrate the fit-for-purpose of this novel endpoint according to regulatory guidance.
• To integrate the DHT-derived endpoint into a clinical development program for a menopause-related treatment.

Main Methods:

• A multi-stakeholder collaboration (drug developer, DHT provider, platform provider) was formed to develop the endpoint.
• Established frameworks and prior work were leveraged, alongside gap analyses and evidence curation on a collaboration platform.
• The DHT-derived endpoint (Sleepiz One+) was implemented in a phase 2 pilot study, with data validated against polysomnography.

Main Results:

• The novel DHT-derived endpoint demonstrated fit-for-purpose through validation against polysomnography.
• Regulatory feedback supported the incorporation of the DHT-derived endpoint into elinzanetant's clinical development.
• The DEEP Stack model facilitated the structuring of data for regulatory submission.

Conclusions:

• The joint development and validation of a DHT-derived sleep endpoint offer a new approach for assessing SDM.
• This collaborative effort and generated evidence can support further DHT development and regulatory acceptance.
• The validated endpoint has the potential to enhance clinical trials for menopause-related sleep disturbances.