Tonsillectomy in Adults With Tonsillar Hypertrophy and Obstructive Sleep Apnea

NCT02204696 | Withdrawn

• 1 other identifier: HS-13-00794
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea; obstructive sleep apnea; sleepiness; quality of life

Outcome Measures

Primary Outcomes (1)

• apnea-hypopnea index

  This will be determined by home sleep study.

  8 weeks

Secondary Outcomes (2)

• Epworth Sleepiness Scale score

  8 weeks

• Functional Outcomes of Sleep Questionnaire score

  8 weeks

Other Outcomes (1)

• Insomnia Severity Index

  8 weeks

Study Arms (1)

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

Interventions

Tonsillectomy PROCEDURE

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.

Tonsillectomy

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with obstructive sleep apnea and tonsillar hypertrophy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Henry Ford Health System: collaborator

Study Sites (1)

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleepiness

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: December 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)