Tonsillectomy in Adults With Tonsillar Hypertrophy and Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT02204696|
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : July 30, 2014
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment|
|Obstructive Sleep Apnea||Procedure: Tonsillectomy|
Purpose: To determine if tonsillectomy eliminates symptoms of obstructive sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with normal soft palate and uvula length.
Specific Aims: 1. To determine if tonsillectomy eliminates obstructive sleep apnea as determined by polysomnography. 2. To determine if tonsillectomy eliminates excessive daytime sleepiness and other obstructive sleep apnea symptoms.
Rationale: Current surgical procedures for obstructive sleep apnea include tonsillectomy with soft palate surgery (including uvulopalatopharyngoplasty). Tonsillectomy alone may provide sufficient benefit in adults with marked tonsillar hypertrophy and normal soft palate and uvula length, avoiding the need for additional soft palate surgery.
Intervention: Tonsillectomy will be performed as standard of care, in patients who would be undergoing said surgery regardless of study. Study intervention includes multiple home sleep studies to determine effect of tonsillectomy in impacting symptoms of sleep apnea.
Study Population: Inclusion criteria: Subjects must be at least 18 years old, have documented obstructive sleep apnea; be willing to undergo 3 home sleep studies; and have markedly hypertrophic (3+ or 4+) tonsils. Exclusion criteria: Subjects must not have any craniofacial abnormality; normal soft palate length (<4 cm) and uvula length ((<2 cm); must have no history of chronic obstructive pulmonary disease, untreated psychological disorder, restless leg syndrome, alcohol or drug abuse; must have a body mass index <35; must not plan to use continuous positive airway pressure during the study period, and lack significant nasal obstruction. The subjects will serve as their own control.
Methods and Follow Up: This two-center prospective study will include evaluation of demographics, clinical symptoms, extent of tonsillar hypertrophy, sleep habits, and home sleep studies. All subjects will undergo a 4-8 week period of watchful waiting (standard minimum delay for scheduling surgery), followed by tonsillectomy alone, with values at baseline compared to a period of watchful waiting and post-tonsillectomy.
Outcomes: Primary outcome is apnea-hypopnea index (from home sleep study). Exploratory outcomes include other sleep study results and subjective assessments (sleep-related quality of life with the Functional Outcome of Sleep Questionnaire and daytime sleepiness with the Epworth Sleepiness Scale).
Statistics and Plans for Analysis: The minimum sample size is 44 subjects, with an enrollment target of 60 subjects that will accommodate a 25% dropout rate. Standard statistical tests (e.g., paired t-tests for continuous measures) will evaluate potential differences between outcome measures at baseline vs. post-watchful waiting and baseline vs. post-tonsillectomy. Similarly, standard and appropriate statistical tests (e.g, t-tests for continuous measures) will compare changes with watchful waiting vs. tonsillectomy (e.g., baseline vs. post-watchful against baseline vs. post-tonsillectomy).
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||The Role of Tonsillectomy in Adults With Marked Tonsillar Hypertrophy and Obstructive Sleep Apnea|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
All participants will undergo baseline sleep study, a second preoperative sleep study after a period of watchful waiting, and a postoperative sleep study.
Study participants will be scheduled for tonsillectomy based on clinical indications, with the need for surgery determined prior to study enrollment and not based on study enrollment.
- apnea-hypopnea index [ Time Frame: 8 weeks ]This will be determined by home sleep study.
- Epworth Sleepiness Scale score [ Time Frame: 8 weeks ]This measure of daytime sleepiness will be assessed by questionnaire.
- Functional Outcomes of Sleep Questionnaire score [ Time Frame: 8 weeks ]This measure of sleep-related quality of life will be assessed by questionnaire.
- Insomnia Severity Index [ Time Frame: 8 weeks ]This measure of insomnia severity will be assessed by questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204696
|United States, California|
|Keck Hospital of USC|
|Los Angeles, California, United States, 90033|