Effects of Thyroidectomy on Obstructive Sleep Apnea in Patients Suffering From Goiters

NCT05391945 | Recruiting

• 1 other identifier: THYR_MB/AR/KP_2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Literature regarding effects of goiter on the occurrence of obstructive sleep apnea (OSA) remains scarce. Reports have described cases of OSA in patients suffering from goiters, resolved after thyroidectomy. It has been recently shown that goiters of a total volume exceeding 25 mL leads to \>30% tracheal compression. The aims of the present study is to assess 1) the prevalence of OSA in patients suffering from goiters and planned for thyroidectomy 2) the role of thyroidectomy in OSA resolution in patients suffering from pre-operative OSA 3) the identification of predictors for persisting OSA.

Conditions

Goiter

Outcome Measures

Primary Outcomes (1)

• the prevalence of obstructive sleep apnea in patients suffering from goiters and planned for partial/total thyroidectomy

  percentage

  one month

Secondary Outcomes (2)

• OSA resolution after thyroidectomy in patients suffering from pre-operative OSA

  three months after surgery

• body mass index is increased in patients with persisting OSA after surgery

  three months after surgery

Study Arms (1)

goiter

Patients referred for partial/total thyroidectomy for goiter

Diagnostic Test: polysomnography

Interventions

polysomnography DIAGNOSTIC_TEST

Patient will be assessed by home Polysomnography(PSG), one night, Pulmonary function tests, including respiratory muscle strength, and comprehensive biological assessment of thyroid function.

Also known as: pulmonary function test, thyroid function tests

goiter

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients planned for partial/total thyroidectomy for goiter

You may qualify if:

• °patients planned for thyroidectomy for goiter

You may not qualify if:

• previous cervical surgery/radiotherapy
• language barrier
• chest disease known to narrow upper airways

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU Saint Pierre

Brussels, 1000, Belgium

RECRUITING

MeSH Terms

Conditions

Goiter

Interventions

Polysomnography; Respiratory Function Tests; Thyroid Function Tests

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Diagnostic Techniques, Endocrine

Central Study Contacts

Marie Bruyneel, MD,PhD

CONTACT

+3225354219; marie.bruyneel@stpierre-bru.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 26, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)