Sleep Apnea, ObstructiveT1D and OSANCT06915831
Type 1 Diabetes and Obstructive Sleep Apnea
A study testing Continuous positive airway pressure (CPAP) in people with Sleep Apnea, Obstructive and Type 1 Diabetes (T1D), run by University of Chicago at 1 site in United States.
Trial summary
The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Type 1 Diabetes (T1D)
- What is being tested?
- Continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2025to 31 Aug 2029
- Phase
- Interventional
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 to 50 years old
- Type 1 Diabetes on insulin pump therapy and using a CGM device with an GMI (glucose management indicator) between 5.5 and 8.5% with hemoglobin in the normal range at screening
- OSA by home sleep apnea test
Who cannot join
- Regular and adherent CPAP use per clinical guidelines
- Requiring oxygen or advanced positive airway pressure modalities during sleep
- Having a 'fall-asleep' or 'near miss' accident in the past 6-months
- Shift work
- Severe hypoglycemia (≥1 episode in the past 3 months or diagnosis of hypoglycemic unawareness)
- ≥1 trip to emergency room for poor glucose management in the past 6 months
Show all 19Show fewer
- Proliferative retinopathy
- Fasting triglycerides >400mg/dL,
- Liver transaminases >2 times upper limit of normal,
- Renal transplantation or serum creatinine >1.5 mg/dL
- Anemia (hemoglobin <13.0g/dL in men or <11.6g/dL in women)
- Acute coronary syndrome or stroke past 6 months
- Severe hypertension (blood pressure>180/105 mmHg)
- Any other significant health condition: unstable angina, heart failure requiring hospitalization in the past 6 months, significant heart block or arrhythmias, NYHA Class>2, pulmonary disease with dependence on oxygen or daily use of bronchodilators, active or chronic infection, thyroid disease and other endocrine disorders (e.g. Cushing syndrome, acromegaly)
- Recent major surgery
- Major psychiatric disorder
- Subjects will also be excluded if taking medications that can confound metabolic assessments including systemic glucocorticoids, antipsychotics, thiazide diuretics, beta-blockers, daily use of aminophylline or theophylline, or use of any immunosuppressant.
- Currently pregnant or trying to get pregnant or nursing
- Smoking, alcohol or illegal drug abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Becky Tucker, 773-702-2348, tuckerb@bsd.uchicago.edu
About this study
Official title: Obstructive Sleep Apnea and Glycemic Dysregulation in Adults With Type 1 Diabetes
The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.
Read the detailed description
Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent collapse of upper airway during sleep, resulting in intermittent hypoxia, sleep fragmentation by transient arousals, and poor sleep quality. Continuous positive airway pressure (CPAP), applied at night, is considered the treatment of choice for persons who are diagnosed with OSA. Current evidence suggests that OSA is highly prevalent in adults with T1D and particularly those with moderate-to-severe OSA have poorer glycemic control. Our overall goal is to investigate the role OSA in glycemic dysregulation in adults with T1D.
- Conditions
- Sleep Apnea, Obstructive, Type 1 Diabetes (T1D)
- Being tested
- Continuous positive airway pressure (CPAP)
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP)Device
All-night CPAP will be applied with bedtimes 23:00h to 7:00h.
| Study group | Role | What they receive |
|---|---|---|
| Untreated | No intervention | No treatment for OSA |
| Treated: Continuous positive airway pressure (CPAP) treatment | Active comparator | Treatment for OSA by CPAP Receives: Device: Continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic variability
Glycemic variability will be calculated using a standard metric as percent coefficient of variation (% CV) of glucose values obtained from continuous glucose monitoring (CGM).
Measured: Within 3 months of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start10 Nov 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (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 University of ChicagoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within subjects design
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Esra Tasali, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915831
- Sponsor's protocol ID
- IRB24-2170
- Other IDs
- 1R01HL174685-01
- Acronym
- T1D and OSA
- Status last verified
- Nov 2025
- First submitted
- 31 Mar 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea and Glycemic Dysregulation in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06915831
- Acronym / sponsor ID
- T1D and OSA / IRB24-2170
- Conditions
- Sleep Apnea, Obstructive, Type 1 Diabetes (T1D)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 8 Apr 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.
The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.
Detailed description
Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent collapse of upper airway during sleep, resulting in intermittent hypoxia, sleep fragmentation by transient arousals, and poor sleep quality. Continuous positive airway pressure (CPAP), applied at night, is considered the treatment of choice for persons who are diagnosed with OSA. Current evidence suggests that OSA is highly prevalent in adults with T1D and particularly those with moderate-to-severe OSA have poorer glycemic control. Our overall goal is to investigate the role OSA in glycemic dysregulation in adults with T1D.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within subjects design
| Arm | Type | Receives |
|---|---|---|
| Untreated | No intervention | –No treatment for OSA |
| Treated: Continuous positive airway pressure (CPAP) treatment | Active comparator | Device: Continuous positive airway pressure (CPAP)Treatment for OSA by CPAP |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18 to 50 years old
- Type 1 Diabetes on insulin pump therapy and using a CGM device with an GMI (glucose management indicator) between 5.5 and 8.5% with hemoglobin in the normal range at screening
- OSA by home sleep apnea test
Key exclusion criteria (19 listed)
- Regular and adherent CPAP use per clinical guidelines
- Requiring oxygen or advanced positive airway pressure modalities during sleep
- Having a 'fall-asleep' or 'near miss' accident in the past 6-months
- Shift work
- Severe hypoglycemia (≥1 episode in the past 3 months or diagnosis of hypoglycemic unawareness)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressure (CPAP)All-night CPAP will be applied with bedtimes 23:00h to 7:00h. | Device | Treated: Continuous positive airway pressure (CPAP) treatment |
Primary outcome
Glycemic variability
Time frame: Within 3 months of screening
Glycemic variability will be calculated using a standard metric as percent coefficient of variation (% CV) of glucose values obtained from continuous glucose monitoring (CGM).
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 20 Jan 2026.
- 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.
Esra Tasali, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure (CPAP) in people with Sleep Apnea, Obstructive and Type 1 Diabetes (T1D), run by University of Chicago at 1 site in United States.
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 19 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 20 Jan 2026. 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 United States. 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 Esra Tasali, MD (7738342663, etasali@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic variability (time frame: Within 3 months of screening). 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 20 Jan 2026.