Treatment of Sleep Apnea to Improve Metabolic Health

Recruiting

• Conditions: Sleep Apnea, Obstructive; Metabolism; CPAP; Patients Above 18 Years

• Registration Number: NCT06848647
• Lead Sponsor: Uppsala University

Brief Summary

Diabetes and prediabetes prevail among obstructive sleep apnea (OSA) patients. OSA and short sleep both detrimentally affect glycemic control regardless of obesity. With 1 in 10 adults having diabetes, 1 in 10 with prediabetes, and an estimated 600,000 affected by OSA in Sweden, attaining glycemic control is crucial. Though continuous positive airway pressure (CPAP) is the most effective treatment for OSA, its application lacks personalization, ignoring factors like comorbidities and sleep duration. Key unanswered questions regarding CPAP's impact on glycemic control include: 1) Does high CPAP adherence optimize glycemic control? 2) Should short sleep be addressed alongside OSA treatment for glycemic control? 3) Does long-term diabetes hinder CPAP's glycemic control efficacy? The purpose of this project is to enable precision health in CPAP treatment and producing a personalized treatment model for achieving glycemic control in patients with OSA, treated with CPAP. Taking advantage of a large unique patient cohort (600 patients followed over 18 months) with extensive and objective measures on CPAP adherence, OSA reduction, sleep duration, as well as information on comorbidities, anthropometric, lifestyle data, and a wide range of biomarkers related to glycemic control. This comprehensive approach and in-depth analysis will address these questions and generate a personalized treatment strategy for glycemic control in CPAP-treated OSA patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-13
• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Primary Completion: 2027-12-20
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patients diagnosed with obstructive sleep apnea
• Planned for CPAP treatment
• 18 years and above

Exclusion Criteria

• Patient not wanting to participate in study
• Non-Swedish speaking
• Judged by physician as non-fit for study participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Homeostatic model assessment for insulin resistance (HOMA-IR)	From enrollment to the end of treatment at 12 months	Clinical marker: HOMA-IR calculated from blood glucose and serum insuling
Glycated hemoglobin (HbA1c)	From enrollment to the end of treatment at 12 months	Clinical maker: glycated hemoglobin (HbA1c) in % and mmol/mol
Blood glucose	From enrollment to the end of treatment at 12 months	Clinical marker: blood glucose in mmol/L
Serum insulin	From enrollment to the end of treatment at 12 months	Clinical marker: serum insulin in mU/L
Plasma triglycerides	From enrollment to the end of treatment at 12 months	Clinical marker: Triglycerides in mg/dL
Plasma cholesterol	From enrollment to the end of treatment at 12 months	Clinical marker: plasma cholesterol in mg/dL
HDL-cholesterol	From enrollment to the end of treatment at 12 months	Clinial marker: high-density lipoprotein (HDL) cholesterol in mg/dL
LDL-cholesterol	From enrollment to the end of treatment at 12 months	Clinical marker: low-density lipoprotein (LDL) cholesterol in mg/dL

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Sweden