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

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ClinicalTrials.gov Identifier: NCT03506022
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: standard polysomnography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes (APT1)
Actual Study Start Date : January 12, 2018
Estimated Primary Completion Date : April 11, 2019
Estimated Study Completion Date : April 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
patients with type 1 mellitus diabetes
All participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters
Other: standard polysomnography
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 Measures :
  1. Prevalence of obstructive sleep apnea syndrome confirmed by polysomnography an apnea hypopnea Index ≥ 15 [ Time Frame: 3 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506022


Locations
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France
Chu Amiens Picardie Recruiting
Amiens, Picardie, France, 80000
Contact: Salha FENDRI    (+33)3 22 45 58 96    Fendri.salha@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03506022     History of Changes
Other Study ID Numbers: PI2017_843_0019
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Sleep apnea syndrome, polysomnography and glucose monitoring continu glycemia (CGMS )

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Sleep Apnea Syndromes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases