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Tonsillectomy in Adults With Tonsillar Hypertrophy and Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02204696
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : July 30, 2014
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
Henry Ford Health System
Information provided by (Responsible Party):
Eric Kezirian, University of Southern California

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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Procedure: Tonsillectomy

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).

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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.
Procedure: Tonsillectomy
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.




Primary Outcome Measures :
  1. apnea-hypopnea index [ Time Frame: 8 weeks ]
    This will be determined by home sleep study.


Secondary Outcome Measures :
  1. Epworth Sleepiness Scale score [ Time Frame: 8 weeks ]
    This measure of daytime sleepiness will be assessed by questionnaire.

  2. Functional Outcomes of Sleep Questionnaire score [ Time Frame: 8 weeks ]
    This measure of sleep-related quality of life will be assessed by questionnaire.


Other Outcome Measures:
  1. Insomnia Severity Index [ Time Frame: 8 weeks ]
    This measure of insomnia severity will be assessed by questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with obstructive sleep apnea and tonsillar hypertrophy
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

Information from the National Library of Medicine

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


Locations
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United States, California
Keck Hospital of USC
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Henry Ford Health System

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Responsible Party: Eric Kezirian, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02204696    
Other Study ID Numbers: HS-13-00794
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Eric Kezirian, University of Southern California:
sleep apnea
obstructive sleep apnea
sleepiness
quality of life
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypertrophy
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathological Conditions, Anatomical