ObStructive Sleep Apnoea ManageMent in Older AdUlts with Overweight or ObEsity: A Randomized ClinicaL Trial (SAMUEL study)
Key facts
- Where
- Guadalajara és Lleida, SpanyolországSee the 2 sites
- Phase
- 4. fázis
Where in Spanyolország
- Hospital Universitario De Guadalajara SESCAMGuadalajara, SpanyolországToborzás még nem indult
- Hospital Universitari de Santa MariaLleida, SpanyolországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Trial code
- EU 2026-525500-10-00
- Record updated
- 2026. június 29.
- Original description
To determine the best first-line treatment for Obstructive Sleep Apnea (OSA) in older adults (≥65 years) with overweight or obesity by comparing the efficacy of Tirzepatide versus Continuous Positive Airway Pressure (CPAP) and versus an interdisciplinary lifestyle modification intervention, based on the change in the Apnea-Hypopnea Index (AHI) after 24 weeks of treatment.Read full original descriptionShow less
To determine the best first-line treatment for Obstructive Sleep Apnea (OSA) in older adults (≥65 years) with overweight or obesity by comparing the efficacy of Tirzepatide versus Continuous Positive Airway Pressure (CPAP) and versus an interdisciplinary lifestyle modification intervention, based on the change in the Apnea-Hypopnea Index (AHI) after 24 weeks of treatment.
Inclusion: Age >= 65 years; Clinical diagnosis of moderate-to-severe Obstructive Sleep Apnea (OSA) defined by an Apnea-Hypopnea Index (AHI) >= 15 events/h; Body Mass Index (BMI) >= 27 kg/m2; Patients who are candidates for CPAP therapy or lifestyle intervention; Capable of giving signed informed consent.
Exclusion: Previous use of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists within 3 months prior to screening; Diagnosis of Type 1 Diabetes Mellitus; History of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); History of chronic pancreatitis; Major cardiovascular event (infarction, stroke) within the last 6 months; Any condition that, in the investigator's opinion, prevents the patient from completing the study procedures (e.g., severe cognitive impairment); Severe renal impairment (eGFR <30mL/min/1.73m2).