Effects of Thyroidectomy on Obstructive Sleep Apnea in Patients Suffering From Goiters
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: polysomnography.
- Who it may be relevant to
- Registry conditions: Goiter. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- the prevalence of obstructive sleep apnea in patients suffering from goiters and planned for partial/total thyroidectomy [Time frame: one month]
Secondary outcome measures (2)
- OSA resolution after thyroidectomy in patients suffering from pre-operative OSA [Time frame: three months after surgery]
- body mass index is increased in patients with persisting OSA after surgery [Time frame: three months after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- CHU Saint Pierre — Brussels
Identifiers
NCT: NCT05391945 · THYR_MB/AR/KP_2022