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NCT Number: NCT01935765

Sleep Apnea in Type 1 Diabetes

Sleep apnea syndrome is strongly associated to type 2 diabet, partly and this is partly due to obesity. Treatment of sleep apnea may improve hypertension, cardiovascular risk and in some studies diabetes status. Few data are available for type 1 diabetes but suggest that the prevalence of sleep apnea syndrome may be high. We plan to compare the prevalence of sleep apnea syndrome assessed by polysomnography in a sample of type 1 diabetic patients and a control group matched by age, gender and body mass index. The secondary objective is to determine if the presence of an autonomic neuropathy or poorly controlled diabetes (assessed by glycosylated haemoglobin) may or not contribute to the presence of sleep apnea in the diabetic group.

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Key information

About this study

Diagnostic protocol designed to evaluate if if sleep apnea syndrome is more frequent in type 1 diabetes than in general population and therefore deserves to be more systematically suspected and actively diagnosed in this patients. Sleep apnea syndrome is a heavy burden as a matter of quality of life: it is responsible for fatigue, diurnal sleepiness, cognitive impairment, poor and /or non restorative sleep, morning headaches, depressive mood…Adequate treatment provides a rapid and, most of the time, complete relief of these symptoms.

On an other hand, Sleep Apnea is and independent risk factor for cardiovascular mortality and morbidity in young and middle aged subjects, also reversed by treatment. It might be therefore important for type 1 diabetic patients who have already an increased cardiovascular risk to be properly diagnosed for sleep apnea. A systematic screening for sleep apnea is already recommended for patients with type 2 diabetes by experts.

A secondary objective is to determine if the presence of a sleep apnea syndrome in type 1 diabetic patients is associated to an autonomic neuropathy, a poor glycemic control , a poorer quality of life , a poorer quality of sleep, more severe cardiovascular consequences and biological impairment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 99 Type 1 diabetic patients
  • man or woman aged 18 to 60 years
  • diagnosed since at least a year
  • having signed a consent
  • with in a national insurance scheme
  • and 46 healthy volunteers matched by age , gender and body mass index
  • man or woman aged 18 to 60 years
  • having signed a consent
  • with in a national insurance scheme

Exclusion criteria

for both

  • sleep apnea syndrome already known
  • acute respiratory or cardiovascular disease
  • impairment of consciousness
  • sepsis
  • cirrhosis
  • hypnotic, opiate or psychotropic drug treatment 2 weeks ago
  • Pregnant or breast-feeding woman
  • Do not speak French
  • Benefiting from a legal protective measure
  • diabet 1 or 2 just for volunteers people

Treatment and study plan

Polysomnography

Other

Diabetes people: Examination diagnosis of the sleep apnea A night at the hospital

Evaluation of the autonomous nervous system

Other

blood pressure, Heart frequence, deep breath, Orthostatism, Vasalva, Low blood pressure orthostatic

Clinical examination of the sleep

Other

Functional signs, collection of medical histories and associated pathologies, Pittsburgh Sleep Quality Index PSQI, Functional Outcomes of Sleep Questionnaire FOSQ, Epworth Sleepiness Scale ESS, Hospital Anxiety and Depression scale HAD

Clinical examination of diabetology

Other

history of diabet, observance, ophthalmological, renal, macroangiopathic and neuronal complications, Toronto scale, Diabetes Quality of Life (DQOL) Questionnaire

Biological dosages

Other

Hematology, glycemia, lipids, CRP, creatinine, ferritin, glycosylated hemoglobin, transaminase, microalbuminuria, urine test

Electrocardiogram (ECG)

Other

Electrocardiogram (ECG)

Carotid echography

Other

Carotid echography

Blood pressure

Other

Blood pressure

Primary outcomes

  1. Compare the prevalence of sleep apnea syndrome by polysomnography between type 1 diabetic patients and healthy volunteers

    Time frame: 3 months

    Determine if prevalence of the sleep apnea syndrome is more raised at the patient's diabetics of type 1 (DT1) than in the general population and to collect elements to specify the determiners of this association (presence of an autonomous neuropathy and glycemic balance).

    sleep apnea syndrome as defined by the International Classification of Sleep Disorders 2

Secondary outcomes

  1. Precise if glycemic balance as defined by glycosylated hemoglobin<7% during the last three months is associated or not to sleep apnea syndrome

    Time frame: 3 months

    Compare diabetic subjects with or without sleep apnea regarding the rate of poorly controlled diabetes (determined by the level of glycosylated haemoglobin)

  2. Precise if the presence of an autonomic neuropathy (positive at 2 tests) is associated or not to sleep apnea syndrome

    Time frame: 3 months

    Compare diabetic subjects with or without sleep apnea regarding presence of autonomic neuropathy determined by clinical assessment

  3. Compare the patients with or without sleep apnea regarding consequences especially cardiovascular markers and coagulation factors

    Time frame: 3 months

    Compare diabetic subjects with or without sleep apnea regarding other cardiovascular risk factors and consequences (intima media thickness)

  4. Determine if the presence of sleep apnea syndrome has an impact upon quality of life and diabetes complications, micro or macroangiopathy

    Time frame: 3 months

    Compare diabetic subjects with or without sleep apnea regarding quality of sleep

  5. Precise clinical symptoms in DT1 patients with Sleep apnea syndrome

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Sleep Apnea in Type 1 Diabetes : Prevalence, Role of Glycemic Control and Autonomic Neuropathy

Acronym: DIASOM

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 5, 2013
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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