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Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes (APT1)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
standard polysomnography
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1 focused on measuring Sleep apnea syndrome, polysomnography and glucose monitoring continu glycemia (CGMS )

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients over 18 years
  • with type 1 mellitus diabetes

Exclusion Criteria:

  • Type-free diabetes (type 1 slow),
  • Age <18 years
  • A poor compliance with the follow-up (meetings unfulfilled without justification).
  • All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).

Sites / Locations

  • Chu Amiens Picardie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with type 1 mellitus diabetes

Arm Description

All participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters

Outcomes

Primary Outcome Measures

Prevalence of obstructive sleep apnea syndrome confirmed by polysomnography an apnea hypopnea Index ≥ 15

Secondary Outcome Measures

Full Information

First Posted
April 13, 2018
Last Updated
July 17, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03506022
Brief Title
Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes
Acronym
APT1
Official Title
Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes (APT1)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
April 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Obstructive sleep apnea (OSA) and Type 2 diabetes are two frequent diseases that occur in adult population. The prevalence of OSA is higher in people with Type 2 diabetes compared with the general population7 ; in addition, the OSA syndrome is almost assessed in obese type 2 diabetes. The relationship between OSA and Type 2 diabetes has been well characterized: the OSA can contribute to increased insulin resistance or glucose intolerance; and, diabetes may worsen sleep-disordered breathing because of autonomic neuropathy8,9. The main link between OSA and Type 2 diabetes is central obesity, which triggers glucose intolerance/insulin resistance and is also an independent risk factor for OSA. Type 1 diabetes is generally not related to obesity; however, sleep-disordered breathing in these patients was described in few reports early as 1985 by pioneers such as Guilleminault5 and the prevalence of OSA is estimated at range 10 to 40% in type 1 diabetes patients. Few studies had evaluated the prevalence of sleep disorders in particular the sleep apnea syndrome in patients with type 1 diabetes and even less their influence on the glycemic control. This study will take place at the CHU of Amiens-Picardie during a one-night hospitalization. The investigators will study in 44 type 1 diabetes mellitus (IAH apnea hypopnea index ≥15) who underwent polysomnography and continuous glucose monitoring of blood glucose

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Sleep apnea syndrome, polysomnography and glucose monitoring continu glycemia (CGMS )

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients over 18 years with type 1 mellitus diabetes will be included. The exclusion criteria are type-free diabetes (type 1 slow), age <18 years, a poor compliance with the follow-up (meetings unfulfilled without justification). All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with type 1 mellitus diabetes
Arm Type
Other
Arm Description
All participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters
Intervention Type
Other
Intervention Name(s)
standard polysomnography
Intervention Description
All participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters : electroencephalogram, electro-oculogram, electromyogram [chin], continuous nasal airflow body position, thoracic and abdominal strain gauges, haemoglobin oxygen saturation (SaO2) with an oximeter (Medatec) attached to finger. Blood pressure was measured in the evening during the physical examines, and then the CGMS recording startedpressure was measured in the evening during the physical examines, and then the CGMS recording started
Primary Outcome Measure Information:
Title
Prevalence of obstructive sleep apnea syndrome confirmed by polysomnography an apnea hypopnea Index ≥ 15
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients over 18 years with type 1 mellitus diabetes Exclusion Criteria: Type-free diabetes (type 1 slow), Age <18 years A poor compliance with the follow-up (meetings unfulfilled without justification). All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).
Facility Information:
Facility Name
Chu Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes

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