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RecruitingNCT06915831T1D and OSAUpdated Jan 20, 2026

Type 1 Diabetes and Obstructive Sleep Apnea

An interventional study of Continuous positive airway pressure (CPAP) in Sleep Apnea, Obstructive and Type 1 Diabetes (T1D), sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by University of Chicago · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sleep Apnea, Obstructive
  • Type 1 Diabetes (T1D)
03

In context

Sleep Apnea, Obstructive

2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.

This study's planned enrollment of 40 is below the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • No intervention
    Untreated

    No treatment for OSA

  • Active comparator
    Treated: Continuous positive airway pressure (CPAP) treatment

    Treatment for OSA by CPAP

    Device: Continuous positive airway pressure (CPAP)

Interventions

  • DeviceContinuous positive airway pressure (CPAP)

    All-night CPAP will be applied with bedtimes 23:00h to 7:00h.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Within 3 months of screening

07

Study locations

1 of 1 sites recruiting
  • University of Chicago
    Chicago, Illinois 60637, United States
    Recruiting
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 14, 2025
  • Informed consent form · Mar 21, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06915831
Lead sponsor
University of Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Apr 8, 2025
Start date
Nov 10, 2025
Primary completion
Aug 31, 2029 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Jan 20, 2026

Study contacts

Esra Tasali, MD
Contact
etasali@bsd.uchicago.edu
7738342663
Becky Tucker
Contact
tuckerb@bsd.uchicago.edu
7737022348
Esra Tasali, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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