Sleep Apnea in Type 1 Diabetes

NCT ID: NCT01935765

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2019-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Type 1 Diabetes, Sleep Apnea Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diabetes people

99 Type 1 diabetic patients aged 18 to 60 years, diagnosed since at least a year

Group Type: EXPERIMENTAL

Polysomnography

Intervention Type: OTHER

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

Evaluation of the autonomous nervous system

Intervention Type: OTHER

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

Clinical examination of the sleep

Intervention Type: 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

Intervention Type: OTHER

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

Biological dosages

Intervention Type: OTHER

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

Electrocardiogram (ECG)

Intervention Type: OTHER

Electrocardiogram (ECG)

Carotid echography

Intervention Type: OTHER

Carotid echography

Blood pressure

Intervention Type: OTHER

Blood pressure

healthy volunteers (controll group)

46 healthy volunteers matched by age, gender and body mass index

Group Type: EXPERIMENTAL

Polysomnography

Intervention Type: OTHER

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

Evaluation of the autonomous nervous system

Intervention Type: OTHER

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

Clinical examination of the sleep

Intervention Type: 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

Biological dosages

Intervention Type: OTHER

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

Electrocardiogram (ECG)

Intervention Type: OTHER

Electrocardiogram (ECG)

Carotid echography

Intervention Type: OTHER

Carotid echography

Blood pressure

Intervention Type: OTHER

Blood pressure

Interventions

Polysomnography

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

Intervention Type: OTHER

Evaluation of the autonomous nervous system

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

Intervention Type: OTHER

Clinical examination of the sleep

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

Intervention Type: OTHER

Clinical examination of diabetology

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

Intervention Type: OTHER

Biological dosages

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

Intervention Type: OTHER

Electrocardiogram (ECG)

Electrocardiogram (ECG)

Intervention Type: OTHER

Carotid echography

Carotid echography

Intervention Type: OTHER

Blood pressure

Blood pressure

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Véronique Viot-Blanc, MD

Role: STUDY_DIRECTOR

Lariboisiere Hospital, APHP

Pierre-Jean Guillausseau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lariboisiere Hopistal, APHP

Locations

Véronique Viot-Blanc

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

P111009

Identifier Type: -

Identifier Source: org_study_id