We're sorry, but this trial is no longer enrolling volunteers.
THE ROLE OF TONSILLECTOMY IN ADULTS WITH MARKED TONSILLAR HYPERTROPHY AND OBSTRUCTIVE SLEEP APNEA
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).
Inclusion and Exclusion 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
- 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
- Keck Hospital of USC, Los Angeles, California, 90033