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ObStructive Sleep Apnoea ManageMent in Older AdUlts with Overweight or ObEsity: A Randomized ClinicaL Trial (SAMUEL study)
EU CTIS ID: 2026-525500-10-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
- Severe renal impairment (eGFR <30mL/min/1.73m2)
- Major cardiovascular event (infarction, stroke) within the last 6 months.
See the full eligibility criteria
- 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.
- 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.
- Severe renal impairment (eGFR <30mL/min/1.73m2)
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.