Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes

NCT ID: NCT03506022

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-12
• Study Completion Date: 2019-04-11

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

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

standard polysomnography

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Amiens Picardie

Amiens, Picardie, France

Countries

France

Other Identifiers

PI2017_843_0019

Identifier Type: -

Identifier Source: org_study_id