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

Sponsor
Centre Hospitalier Universitaire Saint Pierre (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05391945
Collaborator
(none)
100
Enrollment
27
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: polysomnography

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effects of Thyroidectomy on Obstructive Sleep Apnea in Patients Suffering From Goiters
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
goiter

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.
Other Names:
  • pulmonary function test
  • thyroid function tests

    		•

    Outcome Measures

    Primary Outcome Measures

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

      percentage

    Secondary Outcome Measures

    1. OSA resolution after thyroidectomy in patients suffering from pre-operative OSA [three months after surgery]

      percentage

    2. body mass index is increased in patients with persisting OSA after surgery [three months after surgery]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    °patients planned for thyroidectomy for goiter

    Exclusion Criteria:

    • previous cervical surgery/radiotherapy

    • language barrier

    • chest disease known to narrow upper airways

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire Saint Pierre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire Saint Pierre
    ClinicalTrials.gov Identifier:
    NCT05391945
    Other Study ID Numbers:
    • THYR_MB/AR/KP_2022
    First Posted:
    May 26, 2022
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sleep Apnea, Obstructive
    Goiter

    Study Results

    No Results Posted as of Jul 26, 2022