Clinical trial NCT06848647: Treatment of Sleep Apnea to Improve Metabolic Health
Official title: Treatment of Sleep Apnea to Improve Metabolic Health - a Novel Approach to Unanswered Questions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea, Obstructive
Metabolism
CPAP
Patients Above 18 Years
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2025-02-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Homeostatic model assessment for insulin resistance (HOMA-IR)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Glycated hemoglobin (HbA1c)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Blood glucose
timeFrame: From enrollment to the end of treatment at 12 months
measure: Serum insulin
timeFrame: From enrollment to the end of treatment at 12 months
measure: Plasma triglycerides
timeFrame: From enrollment to the end of treatment at 12 months
measure: Plasma cholesterol
timeFrame: From enrollment to the end of treatment at 12 months
measure: HDL-cholesterol
timeFrame: From enrollment to the end of treatment at 12 months
measure: LDL-cholesterol
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
References: