Treatment of Sleep Apnea to Improve Metabolic Health (GLYCOSACT)

Treatment of Sleep Apnea to Improve Metabolic Health - a Novel Approach to Unanswered Questions

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Jenny Theorell-Haglow, A.Prof, PhD; Phone Number: +46 18 6110242; Email: jenny.theorell-haglow@medsci.uu.se

Study Locations

• Sweden
  • Uppsala, Sweden
    • Recruiting
    • Uppsala University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Uppsala University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2023-01150-01; 2023-05223-02; 20230298 (Swedish Heart Lung Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No