Clinical trial NCT02204696: Tonsillectomy in Adults With Tonsillar Hypertrophy and Obstructive Sleep Apnea
Official title: The Role of Tonsillectomy in Adults With Marked Tonsillar Hypertrophy and Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea
obstructive sleep apnea
sleepiness
quality of life
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Henry Ford Health System
First posted: 2014-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with obstructive sleep apnea and tonsillar hypertrophy

Brief summary: The purpose of the study is 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: apnea-hypopnea index
timeFrame: 8 weeks
Secondary outcomes:
measure: Epworth Sleepiness Scale score
timeFrame: 8 weeks
measure: Functional Outcomes of Sleep Questionnaire score
timeFrame: 8 weeks
Other outcomes:
measure: Insomnia Severity Index
timeFrame: 8 weeks
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
Study officials:
References: