Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome

NCT ID: NCT02789696

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 880 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-05-31

Brief Summary

Prevalence of sleep apnea syndrome in patients with acromegaly is about 70%. It seems that comorbidities of arterial hypertension or type 2 diabetes are more severe in patients with acromegaly and sleep apnea syndrome. Besides sleep apnea syndrome associated to acromegaly gives rise to few symptoms, that explains it is under diagnosed. The mechanisms of the association are based on maxillofacial modifications linked to acromegaly, a thickening of soft tissues with deposits of glyco-aminoglycanes but probably also because of the associated obesity, of the potential existence of a goiter and a muscular dystrophy of the dilatative muscles of the pharynx.

At present, no study clearly documented prevalence of acromegaly in a diagnostic consultation for sleep apnea syndrome.

Detailed Description

60 investigators will participate to this study. They will be chosen among those participating to the sleep observatory of the federation of pneumology (www.osfp.fr).

All participating pneumologists would have to fill in the questionnaire (co-morbidities, concomitant treatments, biological analysis) directly online and also clinical signs and symptoms of acromegaly. A blood test for the insulin-like growth factor (IGF-1) dosage will be systematically prescribed to the patient. Pneumologists will have to include all consecutive patients presenting with sleep apnea syndrome suspicion.

According to first IGF-1 results, patients may have to do a second blood test in a referenced laboratory to confirm the dosage.

Conditions

Sleep Apnea Syndrome

Study Design

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

Study Groups

Acromegaly

Diagnosis of acromegaly

Group Type: OTHER

Diagnosis of acromegaly

Intervention Type: OTHER

Biological analysis of IGF-1

Interventions

Diagnosis of acromegaly

Biological analysis of IGF-1

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Body mass index < 40 kg/m2
• Patient consulting for sleep breathing disorder
• Informed consent signed
• patient covered by french health insurance

Exclusion Criteria

• Other sleep disorder already diagnosed
• Pregnant women
• Patients participating in an other study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Louis PEPIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital Grenoble

Grenoble, Isère, France

Countries

France

Other Identifiers

13CHUG37

Identifier Type: -

Identifier Source: org_study_id