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

Goiter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391945
• Other study ID #: THYR_MB/AR/KP_2022
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: Marie Bruyneel, MD,PhD
• Phone: +3225354219
• Email: marie.bruyneel[@]stpierre-bru.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Introduction

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 partial/total thyroidectomy 2) the role of thyroidectomy in OSA resolution in patients suffering from pre-operative OSA 3) the identification of predictors for persisting OSA.

Methods

Design Prospective study Settings Tertiary referral center, university hospital Patients Patients referred for partial/total thyroidectomy for goiter Baseline assessment All patients planned for thyroidectomy will be prospectively included. Exclusion criteria will be: previous cervical surgery/radiotherapy, language barrier, chest disease known to narrow upper airways.

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

Follow up Three months after thyroidectomy, the same assessment will be repeated.

Statistical analysis

Statistical analysis will be performed to determine the percentage of patients suffering from OSA before surgery (apnea-hypopnea index (AHI) >5/hour of sleep on PSG). As the aim of the present study is to assess the role of thyroidectomy in OSA resolution, we will compare pre- and post-thyroidectomy PSG results in patients exhibiting AHI >5/hour of sleep (chi square test). OSA resolution will be defined as decrease in AHI > 50 % or reduction of AHI <5hour of sleep. As one of the secondary aim is the identification of predictors for persisting OSA, multivariate analysis will be performed to assess factors of persisting OSA, among age, neck circumference, body mass index, sex, pre/post menopausal status and pulmonary function tests parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

°patients planned for thyroidectomy for goiter

Exclusion Criteria:

• previous cervical surgery/radiotherapy

• language barrier

• chest disease known to narrow upper airways

Related Conditions & MeSH terms

• Goiter
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Belgium	CHU Saint Pierre	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the prevalence of obstructive sleep apnea in patients suffering from goiters and planned for partial/total thyroidectomy	percentage	one month
Secondary	OSA resolution after thyroidectomy in patients suffering from pre-operative OSA	percentage	three months after surgery
Secondary	body mass index is increased in patients with persisting OSA after surgery	weight and height will be combined to report BMI in kg/m2	three months after surgery