Facial and hand analysis, sleep apnea and speech in patients with acromegaly: a prospective study to investigate changes in craniofacial and hand characteristics, sleep apnea and speech during treatment and after remission.

Completed

• Conditions: 10052547; Growth hormone excess; 10046304; 10040790

• Registration Number: NL-OMON41364
• Lead Sponsor: Endocriene ziekten

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Newly diagnosed acromegaly
- Diagnosis is biochemically confirmed by an increased IGF-1 level (mean +2 standard deviations for age) and insufficient suppression of serum GH levels (e.g. GH levels >= 2mU/l) during oral glucose tolerance test.
- Subjects should be over 18 years old with the ability to read and comprehend the Dutch language

Exclusion Criteria

- Pregnancy
- Maxillofacial surgical treatment in the past.
- Hand surgery in the past
- Speech pathology unrelated to acromegaly

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Parameters of facial analysis with 3D stereophotography and cone beam CT and<br /><br>hand analysis with 3D stereophotography respectively, biochemical parameters of<br /><br>disease activity, disease related and general QOL using the AcroQol and RAND-36<br /><br>questionnaires, speech analysis and the voice handicap index questionnaire and<br /><br>severity of sleep apnea using complete overnight polysomnography and the<br /><br>Epworth sleepiness scale questionnaire. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In vitro inflammatory cytokineproduction and foam cell formation of monocytes<br /><br>obtained from patiënts with acromegaly</p><br>