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

Primary Purpose

Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnosis of acromegaly
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Grenoble

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Acromegaly

Arm Description

Diagnosis of acromegaly

Outcomes

Primary Outcome Measures

determination of acromegaly prevalence
IGF-1 (insulin-like growth factor-1) quantification in blood punction

Secondary Outcome Measures

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.

Full Information

First Posted
May 11, 2016
Last Updated
March 19, 2020
Sponsor
University Hospital, Grenoble
Collaborators
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT02789696
Brief Title
Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome
Acronym
ACROSAS
Official Title
Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome: A Prospective, National and Multicentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Ipsen

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
880 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acromegaly
Arm Type
Other
Arm Description
Diagnosis of acromegaly
Intervention Type
Other
Intervention Name(s)
Diagnosis of acromegaly
Intervention Description
Biological analysis of IGF-1
Primary Outcome Measure Information:
Title
determination of acromegaly prevalence
Description
IGF-1 (insulin-like growth factor-1) quantification in blood punction
Time Frame
1 year
Secondary Outcome Measure Information:
Title
description of clinical signs of acromegaly associated to sleep apnea syndrome (Epworth scale)
Description
Score to Epworth scale will be compared between patients with sleep apnea syndrome with acromegaly and patients with sleep apnea syndrome only.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis PEPIN, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38700
Country
France

12. IPD Sharing Statement

Learn more about this trial

Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome

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