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

March 19, 2020 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

880

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isère
      • Grenoble, Isère, France, 38700
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Acromegaly
Diagnosis of acromegaly
Other: Diagnosis of acromegaly
Biological analysis of IGF-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determination of acromegaly prevalence
Time Frame: 1 year
IGF-1 (insulin-like growth factor-1) quantification in blood punction
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
description of clinical signs of acromegaly associated to sleep apnea syndrome (Epworth scale)
Time Frame: 1 year
Score to Epworth scale will be compared between patients with sleep apnea syndrome with acromegaly and patients with sleep apnea syndrome only.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Ipsen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13CHUG37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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