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Recruiting NCT06848647

Treatment of Sleep Apnea to Improve Metabolic Health

Observational Sleep Apnea, Obstructive Metabolism CPAP Patients Above 18 Years

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sleep Apnea, Obstructive, Metabolism, CPAP, Patients Above 18 Years. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Homeostatic model assessment for insulin resistance (HOMA-IR) [Time frame: From enrollment to the end of treatment at 12 months]
  • Glycated hemoglobin (HbA1c) [Time frame: From enrollment to the end of treatment at 12 months]
  • Blood glucose [Time frame: From enrollment to the end of treatment at 12 months]
  • Serum insulin [Time frame: From enrollment to the end of treatment at 12 months]
  • Plasma triglycerides [Time frame: From enrollment to the end of treatment at 12 months]
  • Plasma cholesterol [Time frame: From enrollment to the end of treatment at 12 months]
  • HDL-cholesterol [Time frame: From enrollment to the end of treatment at 12 months]
  • LDL-cholesterol [Time frame: From enrollment to the end of treatment at 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Uppsala University — Uppsala

Identifiers

NCT: NCT06848647 · 2023-01150-01; 2023-05223-02 · 20230298

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗