2026-525500-10-00Not yet recruitingPhase 4
ObStructive Sleep Apnoea ManageMent in Older AdUlts with Overweight or ObEsity: A Randomized ClinicaL Trial (SAMUEL study)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 345 (estimated)
- First submitted
- 8 Apr 2026
- Start date
- 1 Jul 2026
- Lead sponsor
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Diseases
- Obesity
- EU CT number
- 2026-525500-10-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 345
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 65 or older with moderate-to-severe obstructive sleep apnoea and overweight or obesity. It compares tirzepatide, CPAP and a lifestyle programme.
- Age
- 65 years or older
- Sex
- All sexes can join
- Disease stage
- Moderate-to-severe obstructive sleep apnoea (Apnea-Hypopnea Index of 15 events/h or more) and Body Mass Index of 27 kg/m2 or more
- Earlier treatment
- Must not have used GLP-1 receptor agonists or GIP/GLP-1 receptor agonists in the 3 months before screening
Main reasons for not taking part
- Type 1 diabetes
- History of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- History of chronic pancreatitis
- Severe kidney impairment (eGFR below 30 mL/min/1.73m2)
- Heart attack or stroke within the last 6 months
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous use of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists within 3 months prior to screening.
Other illness
- 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).
Lab values
- Severe renal impairment (eGFR <30mL/min/1.73m2)
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario De Guadalajara SESCAM | Guadalajara | Spain | Not yet recruiting |
| Hospital Universitari de Santa Maria | Lleida | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.