Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome

Sleep Apnea Syndrome Clinical Trial

— ACROSAS  

Official title:

Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome: A Prospective, National and Multicentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789696
• Other study ID #: 13CHUG37
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: May 2016

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: May 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly
• Apnea
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Syndrome

Intervention

Other:
• Diagnosis of acromegaly
Biological analysis of IGF-1

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble	Isère

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determination of acromegaly prevalence	IGF-1 (insulin-like growth factor-1) quantification in blood punction	1 year
Secondary	description of clinical signs of acromegaly associated to sleep apnea syndrome (Epworth scale)	Score to Epworth scale will be compared between patients with sleep apnea syndrome with acromegaly and patients with sleep apnea syndrome only.	1 year