NCT02789696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
880

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

May 11, 2016

Last Update Submit

March 19, 2020

Conditions

Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

  • determination of acromegaly prevalence

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

    1 year

Secondary Outcomes (1)

  • description of clinical signs of acromegaly associated to sleep apnea syndrome (Epworth scale)

    1 year

Study Arms (1)

Acromegaly

OTHER

Diagnosis of acromegaly

Other: Diagnosis of acromegaly

Interventions

Diagnosis of acromegalyOTHER

Biological analysis of IGF-1

Acromegaly

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index \< 40 kg/m2
  • Patient consulting for sleep breathing disorder
  • Informed consent signed
  • patient covered by french health insurance

You may not qualify if:

  • Other sleep disorder already diagnosed
  • Pregnant women
  • Patients participating in an other study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, Isère, 38700, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jean-Louis PEPIN, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2016

First Posted

June 3, 2016

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

May 1, 2016

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

FR(1)