- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02204696
Tonsillectomy in Adults With Tonsillar Hypertrophy and Obstructive Sleep Apnea
The Role of Tonsillectomy in Adults With Marked Tonsillar Hypertrophy and Obstructive Sleep Apnea
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- Keck Hospital of USC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- At least 18 years of age
- Documented obstructive sleep apnea (with central apneas of the total number of apneas plus hypopneas)
- Able to complete all forms in English and follow-up appointments
- Willing to undergo 3 home sleep studies; and markedly hypertrophic (3+ or 4+) tonsils
- Tonsil size of 3+ or 4+ corresponds to tonsils that occupy more than 50% of the space between the tonsillar fossa (side of the throat) and midline
Exclusion Criteria:
- No craniofacial abnormality
- No history of COPD, untreated psychological disorder, other sleep disorder, alcohol or drug abuse
- Body mass index <35 kg/m2
- Unable to tolerate other treatments for obstructive sleep apnea
- Soft palate length > 4 cm
- Uvula length > 2 cm
- No significant nasal obstruction
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Tonsillectomy
All participants will undergo baseline sleep study, a second preoperative sleep study after a period of watchful waiting, and a postoperative sleep study.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
apnea-hypopnea index
Time Frame: 8 weeks
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This will be determined by home sleep study.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epworth Sleepiness Scale score
Time Frame: 8 weeks
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This measure of daytime sleepiness will be assessed by questionnaire.
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8 weeks
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Functional Outcomes of Sleep Questionnaire score
Time Frame: 8 weeks
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This measure of sleep-related quality of life will be assessed by questionnaire.
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8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity Index
Time Frame: 8 weeks
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This measure of insomnia severity will be assessed by questionnaire.
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8 weeks
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-13-00794
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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