TheRapeutic StrAtegies for Obstructive SleeP Apnea in Older Adults with OverweigHt or Obesity: A RandomizEd Clinical TriaL (RAPHAEL study)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-03-30

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

The primary outcome will be the change in OSA severity from baseline to the 6-month follow-up.

Secondary objectives 7

1. Hypoxic Burden, Delta Heart Rate, and Loop Gain: To evaluate the effect of two different interventions—one targeting lifestyle modifications and the other involving pharmacological treatment with semaglutide—compared to standard CPAP therapy on other metrics related to OSA, such as hypoxic burden, delta heart rate, and loop gain.
2. Daytime Sleepiness: To evaluate the effect of two different interventions—one targeting lifestyle modifications and the other involving pharmacological treatment with semaglutide—compared to standard CPAP therapy on daytime sleepiness.
3. Blood Pressure Regulation: To evaluate the effect of two different interventions—one targeting lifestyle modifications and the other involving pharmacological treatment with semaglutide—compared to standard CPAP therapy on blood pressure.
4. Quality of Life, Sleep, Circadian Rhythm, Mental Health, and Cognition: To evaluate the effect of two different interventions—one targeting lifestyle modifications and the other involving pharmacological treatment with semaglutide—compared to standard CPAP therapy on other factors affected by OSA, such as quality of life, sleep quality, circadian rest-activity rhythm, mental health, and cognitive function.
5. Body Weight: To evaluate the effect of two different interventions—one targeting lifestyle modifications and the other involving pharmacological treatment with semaglutide—compared to standard CPAP therapy on body weight.
6. Inflammatory, Oxidative Stress, Obesity, and Cardiovascular Risk Markers: To evaluate the effect of two different interventions—one targeting lifestyle modifications and the other involving pharmacological treatment with semaglutide—compared to standard CPAP therapy on the levels of molecular markers related to inflammation, oxidative stress, obesity, and cardiovascular risk
7. Cost-Effectiveness: To determine the cost-effectiveness of two different interventions—one targeting lifestyle modifications and the other involving pharmacological treatment with semaglutide—in relation to standard CPAP therapy.

Conditions and MedDRA coding

obstructive sleep apnea

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Age ≥65 years.
2. 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)
3. 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 9

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The change in Apnea–Hypopnea Index (AHI) at 6 months

Secondary endpoints 7

1. OSA pathophysiology (hypoxic burden, delta heart rate, loop gain).
2. Symptoms (daytime sleepiness).
3. Blood pressure.
4. Functional and psychological domains (quality of life, sleep quality, circadian rest-activity rhythm, cognitive function, mental health).
5. Body weight.
6. Molecular mechanisms (biomarkers of inflammation, oxidative stress, obesity, and cardiovascular risk).
7. Cost-effectiveness.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Sponsor organisation

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Address

Avinguda De L'Alcalde Rovira Roure 80

City

Lleida

Postcode

25196

Country

Spain

Scientific contact point

Organisation

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Contact name

Diego Arango Del Corro

Public contact point

Organisation

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Contact name

Diego Arango Del Corro

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications