Clinical trial NCT05391945: Effects of Thyroidectomy on Obstructive Sleep Apnea in Patients Suffering From Goiters
Official title: Effects of Thyroidectomy on Obstructive Sleep Apnea in Patients Suffering From Goiters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Goiter
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients planned for partial/total thyroidectomy for goiter

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

°patients planned for thyroidectomy for goiter

Exclusion Criteria:

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

Primary outcomes:
measure: the prevalence of obstructive sleep apnea in patients suffering from goiters and planned for partial/total thyroidectomy
timeFrame: one month
Secondary outcomes:
measure: OSA resolution after thyroidectomy in patients suffering from pre-operative OSA
timeFrame: three months after surgery
measure: body mass index is increased in patients with persisting OSA after surgery
timeFrame: three months after surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Saint Pierre
Study officials:
References: