Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: standard polysomnography

• Registration Number: NCT03506022
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-12
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-20
• Study First Posted: 2018-04-23
• Primary Completion: 2019-04-11
• Study Completion: 2019-04-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with type 1 mellitus diabetes	standard polysomnography	All participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters

Primary Outcome Measures

Name	Time	Method
Prevalence of obstructive sleep apnea syndrome confirmed by polysomnography an apnea hypopnea Index ≥ 15	3 month

Trial Locations

Locations (1)

Chu Amiens Picardie; 🇫🇷 Amiens, Picardie, France