ACROSAS: Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT02789696
Collaborator
Ipsen (Industry)
880
1
1
30
29.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diagnosis of acromegaly
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
880 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome: A Prospective, National and Multicentric Study
Actual Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Acromegaly

Diagnosis of acromegaly

Other: Diagnosis of acromegaly
Biological analysis of IGF-1

Outcome Measures

Primary Outcome Measures

  1. determination of acromegaly prevalence [1 year]

    IGF-1 (insulin-like growth factor-1) quantification in blood punction

Secondary Outcome Measures

  1. description of clinical signs of acromegaly associated to sleep apnea syndrome (Epworth scale) [1 year]

    Score to Epworth scale will be compared between patients with sleep apnea syndrome with acromegaly and patients with sleep apnea syndrome only.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Grenoble Grenoble Isère France 38700

Sponsors and Collaborators

  • University Hospital, Grenoble
  • Ipsen

Investigators

  • Principal Investigator: Jean-Louis PEPIN, MD, PhD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT02789696
Other Study ID Numbers:
  • 13CHUG37
First Posted:
Jun 3, 2016
Last Update Posted:
Mar 20, 2020
Last Verified:
Mar 1, 2020
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2020