Treatment of Sleep Apnea to Improve Metabolic Health

NCT06848647 | Recruiting

• 2 other identifiers: 2023-01150-01; 2023-05223-0220230298
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive; Metabolism; CPAP; Patients Above 18 Years

Outcome Measures

Primary Outcomes (8)

• Homeostatic model assessment for insulin resistance (HOMA-IR)

  Clinical marker: HOMA-IR calculated from blood glucose and serum insuling

  From enrollment to the end of treatment at 12 months

• Glycated hemoglobin (HbA1c)

  Clinical maker: glycated hemoglobin (HbA1c) in % and mmol/mol

  From enrollment to the end of treatment at 12 months

• Blood glucose

  Clinical marker: blood glucose in mmol/L

  From enrollment to the end of treatment at 12 months

• Serum insulin

  Clinical marker: serum insulin in mU/L

  From enrollment to the end of treatment at 12 months

• Plasma triglycerides

  Clinical marker: Triglycerides in mg/dL

  From enrollment to the end of treatment at 12 months

• Plasma cholesterol

  Clinical marker: plasma cholesterol in mg/dL

  From enrollment to the end of treatment at 12 months

• HDL-cholesterol

  Clinial marker: high-density lipoprotein (HDL) cholesterol in mg/dL

  From enrollment to the end of treatment at 12 months

• LDL-cholesterol

  Clinical marker: low-density lipoprotein (LDL) cholesterol in mg/dL

  From enrollment to the end of treatment at 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with obstructive sleep apnea referred to the Sleep Apnea Unit at Uppsala University Hospital for CPAP treatment

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala University

Uppsala, Uppsala County, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Faeces

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Jenny Theorell-Haglow, A.Prof, PhD

CONTACT

+46 18 6110242; jenny.theorell-haglow@medsci.uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 27, 2025
• Study Start: May 13, 2024
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)