An observational study in Goiter, sponsored by Centre Hospitalier Universitaire Saint Pierre. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-02-13.
Sponsored by Centre Hospitalier Universitaire Saint Pierre · Observational
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.
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.
66 studies on the registry are indexed under Goiter; 11 are open to participants now.
This study's planned enrollment of 100 is close to the median of 104 across 23 observational studies indexed under Goiter.
Browse Goiter studies →Centre Hospitalier Universitaire Saint Pierre is the lead sponsor of 78 studies on the registry; 12 are open to participants now.
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patients planned for partial/total thyroidectomy for goiter
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°patients planned for thyroidectomy for goiter
Exclusion Criteria:
Patients referred for partial/total thyroidectomy for goiter
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.
Also known as: pulmonary function test, thyroid function tests
the prevalence of obstructive sleep apnea in patients suffering from goiters and planned for partial/total thyroidectomy
percentage
Time frame: one month
OSA resolution after thyroidectomy in patients suffering from pre-operative OSA
percentage
Time frame: three months after surgery
body mass index is increased in patients with persisting OSA after surgery
weight and height will be combined to report BMI in kg/m2
Time frame: three months after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2022 (actual). Primary completion is estimated for Jun 2026, 45 months after the start.
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Centre Hospitalier Universitaire Saint Pierre