Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source 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

Overall Status Completed
Start Date January 12, 2018
Completion Date April 11, 2019
Primary Completion Date April 11, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Prevalence of obstructive sleep apnea syndrome confirmed by polysomnography an apnea hypopnea Index ≥ 15 3 month
Enrollment 53
Condition
Intervention

Intervention Type: Other

Intervention Name: standard polysomnography

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

Arm Group Label: patients with type 1 mellitus diabetes

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).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Chu Amiens Picardie
Location Countries

France

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: patients with type 1 mellitus diabetes

Type: Other

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

Acronym APT1
Study Design Info

Allocation: N/A

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).

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov