Semaglutide for Obstructive sleep apnea

Inclusion criteria

• {"criterion_text":"- Age ≥65 years.\n- Diagnosis of moderate-to-severe OSA (apnea-hypopnea index [AHI] ≥15 events/h), determined by a home-based sleep apnea test, with clinical indication for active treatment according to the International Consensus Document on OSA (PMID: 33875282)\n- Overweight or obesity (body mass index [BMI] ≥27 kg/m²), consistent with recommendations for semaglutide use in individuals with BMI ≥30 kg/m² or ≥27 kg/m² with weight-related comorbidities."}

Exclusion criteria

• {"criterion_text":"- Presence or suspicion of another sleep disorder.\n- >50% central apneas or Cheyne–Stokes respiration\n- Excessive daytime sleepiness (Epworth Sleepiness Scale ≥18)\n- Participation in a weight-loss program\n- Inability to adhere to interventions or assessments\n- Type 1 or type 2 diabetes.\n- Severe chronic illness (e.g., neoplasia, renal failure, severe COPD, chronic depression).\n- Social or geographic limitations affecting adherence.\n- Any clinical indication for which continuous positive airway pressure (CPAP) is deemed mandatory by the referring physician."}

Primary endpoints

• {"endpoint_text":"- The change in Apnea–Hypopnea Index (AHI) at 6 months","definition_or_measurement_approach":"The primary outcome will be the change in OSA severity from baseline to the 6-month follow-up."}

Secondary endpoints

• {"endpoint_text":"- OSA pathophysiology (hypoxic burden, delta heart rate, loop gain).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Symptoms (daytime sleepiness).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Blood pressure.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Functional and psychological domains (quality of life, sleep quality, circadian rest-activity rhythm, cognitive function, mental health).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Body weight.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Molecular mechanisms (biomarkers of inflammation, oxidative stress, obesity, and cardiovascular risk).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cost-effectiveness.","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

15-01-2026

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

74

Number Of Sites

3

Number Of Participants

345

Primary sponsor

Full Name

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain