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Effect of Sleep Apnea Treatment on Type 1 Diabetes

NCT02316665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-01-06

No results posted yet for this study

Summary

Hypothesis: To address the role of continuous positive airway pressure (CPAP)on nocturnal glycemia in patients having type 1 diabetes and sleep apnea syndrome.

Investigators make the hypothesis that sleep apnea syndrome impacts nocturnal glycemia in type 1 diabetic patients and that continuous positive airway pressure treatment will permit to improve the nocturnal glycemic profile.

Study design: Adult patients with type 1 diabetes will be recruited for an extensive study of sleep habits and assessment of sleep breathing disorders. When patients will present with severe sleep apnea syndrome (apnea-hypopnea index above 30 events/hour) and insufficient glycemic control (HbA1c \> 7.5%), they will be randomized in continuous positive airway pressure treatment or sham-continuous positive airway pressure treatment group for three months.

Main outcome: Nocturnal glycemic control will be assessed for 5 days before and after three months of the allocated treatment.

Conditions

Interventions

DEVICE

continuous positive airway pressure

continuous positive airway pressure treatment during three months with adherence recording

DEVICE

Sham-continuous positive airway pressure

Sham-continuous positive airway pressure during three months with adherence recording

Sponsors & Collaborators

  • Société francophone de pneumologie de langue francaise

    collaborator UNKNOWN

  • ResMed

    collaborator INDUSTRY

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean-Louis Pépin, MD PhD · HP2 INSERM U1042 laboratory, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-10-31
Completion
2015-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02316665 on ClinicalTrials.gov