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NCT Number: NCT05391945

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint Pierre

Brussels, 1000, Belgium

Location status: Recruiting

Location contact

Dimitri Impens, PT

CONTACT

003225353232

Marie Bruyneel, MD PhD

CONTACT

003225354219

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

°patients planned for thyroidectomy for goiter

Exclusion criteria

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

Treatment and study plan

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.

Other names: pulmonary function test, thyroid function tests

Primary outcomes

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

    Time frame: one month

    percentage

Secondary outcomes

  1. OSA resolution after thyroidectomy in patients suffering from pre-operative OSA

    Time frame: three months after surgery

    percentage

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

    Time frame: three months after surgery

    weight and height will be combined to report BMI in kg/m2

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Bruyneel, MD,PhD

CONTACT

[email protected]

+3225354219

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 26, 2022
Registry last updated
Feb 13, 2024

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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