Presentation (CTI)

OBJECTIVES: Digital Health Measurement Collaborative Community asserts "Insomnia" and "Obstructive Sleep Apnea" as the most prevalent sleep disorders. To measure relevant concepts, using Clinical Outcome Assessments (COA) and Digital Health Technologies (DHT) can enhance precision and patient-centricity in clinical trials. COAs capture how patients feel, function or survive and DHTs supply continuous and real time data. We aimed to look at the prevalence of COAs and DHTs in clinical trials with drug interventions and regulatory recommendations for clinical research.
METHODS: We searched ClinicalTrials.gov studies from the last 10 years for "Sleep Initiation and Maintenance Disorders OR Insomnia OR Obstructive Sleep Apnea Syndrome", focusing on drug interventions, and classified primary outcome measures. PROINSIGHT database was searched for "Sleep Apnea Syndromes" and "Sleep Initiation and Maintenance Disorders" to identify clinical guidelines.
RESULTS: In 421 sleep trials over the last 10 years, biomarkers (traditional and digital) were used in 56% as primary outcomes, COAs in 37% and in 18% other measures including clinical judgements, or adverse health outcomes. 13% of trials had composite primary endpoints. The EMA "Guideline on medicinal products for the treatment of insomnia" recommended the use of PROs, PerfO, and non-COA to assess various concepts, including quality of life and sleep parameters, without mentioning endpoint positioning. In the FDA "Guideline for the clinical evaluation of hypnotic drugs", for patients with insomnia, PROs and non-COAs were recommended to assess different sleep parameters, without specifying endpoint positioning.
CONCLUSIONS: In line with regulatory recommendations, primary outcome measures are predominantly biomarkers or COAs in clinical studies for sleep. The burdens to distinguish between traditional and digital biomarkers can be high in study registry data, but it would be interesting to classify granularly to better understand current trends. To support the use of digital biomarkers in clinical studies, updated regulatory guidance and a collective effort in validation are needed.