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OpenTrials
Completed

NCT Number: NCT02789696

Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble

Grenoble, Isère, 38700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnosis of acromegaly

Other

Biological analysis of IGF-1

Primary outcomes

  1. determination of acromegaly prevalence

    Time frame: 1 year

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Ipsen

Registry information

Official study title

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

Acronym: ACROSAS

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Jun 3, 2016
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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