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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524819-37-00
Enrollment
345
Registered
2026-03-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

obstructive sleep apnea

Brief summary

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

Detailed description

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

Interventions

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

Secondary

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

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 31, 2026