FindTrial
Sign In

ObStructive Sleep Apnoea ManageMent in Older AdUlts with Overweight or ObEsity: A Randomized ClinicaL Trial (SAMUEL study)

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525500-10-00
Enrollment
345
Registered
2026-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Obstructive sleep apnea syndrome

Brief summary

Change from baseline in the Apnea-Hypopnea Index (AHI) at week 24.

Detailed description

Change from baseline in the Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI) at week 24., Change from baseline in body weight (kg) and Body Mass Index (BMI) at week 24., Change from baseline in the Montreal Cognitive Assessment (MoCA) score at week 24., Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the 24-week period.

Interventions

DRUGMounjaro 10 mg solution for injection in vial

Sponsors

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in the Apnea-Hypopnea Index (AHI) at week 24.—

Secondary

MeasureTime frame
Change from baseline in the Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI) at week 24., Change from baseline in body weight (kg) and Body Mass Index (BMI) at week 24., Change from baseline in the Montreal Cognitive Assessment (MoCA) score at week 24., Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the 24-week period.—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 30, 2026