Sleep Apnea, ObstructiveGLYCOSACTNCT06848647
Treatment of Sleep Apnea to Improve Metabolic Health
An observational study of Sleep Apnea, Obstructive and Metabolism, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Metabolism, CPAP
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 13 May 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with obstructive sleep apnea referred to the Sleep Apnea Unit at Uppsala University Hospital for CPAP treatment
Who may be able to join
- Patients diagnosed with obstructive sleep apnea
- Planned for CPAP treatment
- 18 years and above
Who cannot join
- Patient not wanting to participate in study
- Non-Swedish speaking
- Judged by physician as non-fit for study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University
Uppsala, Uppsala County
About this study
Official title: 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.
- Conditions
- Sleep Apnea, Obstructive, Metabolism, CPAP, Patients Above 18 Years
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostatic model assessment for insulin resistance (HOMA-IR)
Clinical marker: HOMA-IR calculated from blood glucose and serum insuling
Measured: From enrollment to the end of treatment at 12 months
Glycated hemoglobin (HbA1c)
Clinical maker: glycated hemoglobin (HbA1c) in % and mmol/mol
Measured: From enrollment to the end of treatment at 12 months
Blood glucose
Clinical marker: blood glucose in mmol/L
Measured: From enrollment to the end of treatment at 12 months
Serum insulin
Clinical marker: serum insulin in mU/L
Measured: From enrollment to the end of treatment at 12 months
Plasma triglycerides
Clinical marker: Triglycerides in mg/dL
Measured: From enrollment to the end of treatment at 12 months
Plasma cholesterol
Clinical marker: plasma cholesterol in mg/dL
Measured: From enrollment to the end of treatment at 12 months
HDL-cholesterol
Clinial marker: high-density lipoprotein (HDL) cholesterol in mg/dL
Measured: From enrollment to the end of treatment at 12 months
LDL-cholesterol
Clinical marker: low-density lipoprotein (LDL) cholesterol in mg/dL
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start13 May 2024
- Primary completion20 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848647
- Sponsor's protocol ID
- 2023-01150-01; 2023-05223-02
- Other IDs
- 20230298, 2023
- Acronym
- GLYCOSACT
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Sleep Apnea to Improve Metabolic Health - a Novel Approach to Unanswered Questions
- ClinicalTrials.gov ID
- NCT06848647
- Acronym / sponsor ID
- GLYCOSACT / 2023-01150-01; 2023-05223-02
- Conditions
- Sleep Apnea, Obstructive, Metabolism, CPAP, Patients Above 18 Years
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 13 May 2024 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obstructive sleep apnea referred to the Sleep Apnea Unit at Uppsala University Hospital for CPAP treatment
Key inclusion criteria (3 listed)
- Patients diagnosed with obstructive sleep apnea
- Planned for CPAP treatment
- 18 years and above
Key exclusion criteria (3 listed)
- Patient not wanting to participate in study
- Non-Swedish speaking
- Judged by physician as non-fit for study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Homeostatic model assessment for insulin resistance (HOMA-IR)
Time frame: From enrollment to the end of treatment at 12 months
Clinical marker: HOMA-IR calculated from blood glucose and serum insuling
Glycated hemoglobin (HbA1c)
Time frame: From enrollment to the end of treatment at 12 months
Clinical maker: glycated hemoglobin (HbA1c) in % and mmol/mol
Blood glucose
Time frame: From enrollment to the end of treatment at 12 months
Clinical marker: blood glucose in mmol/L
Serum insulin
Time frame: From enrollment to the end of treatment at 12 months
Clinical marker: serum insulin in mU/L
Plasma triglycerides
Time frame: From enrollment to the end of treatment at 12 months
Clinical marker: Triglycerides in mg/dL
Plasma cholesterol
Time frame: From enrollment to the end of treatment at 12 months
Clinical marker: plasma cholesterol in mg/dL
HDL-cholesterol
Time frame: From enrollment to the end of treatment at 12 months
Clinial marker: high-density lipoprotein (HDL) cholesterol in mg/dL
LDL-cholesterol
Time frame: From enrollment to the end of treatment at 12 months
Clinical marker: low-density lipoprotein (LDL) cholesterol in mg/dL
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive and Metabolism, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Theorell-Haglow, A.Prof, PhD (+46 18 6110242, jenny.theorell-haglow@medsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostatic model assessment for insulin resistance (HOMA-IR) (time frame: From enrollment to the end of treatment at 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.