S.L.E.E.P.: Studying Life Effects and Effectiveness of Palatopharyngoplasty
(closed to enrollment)
Why the “SLEEP” Study?
UPPP, the most common surgical treatment for sleep apnea, significantly improves physiologic abnormalities in selected patients. The procedure often does not, however, cure sleep apnea. Consequently, UPPP appears undervalued as a treatment modality for selected sleep-apnea patients.
Recent studies support that UPPP provides clinically important outcomes such as reduced motor vehicle accidents, mortality and incidence of cardiovascular disease. Moreover, health-related quality of life, possibly the most important outcome to patients, barely has been evaluated in UPPP patients. A multi-site, community-based study will adequately demonstrate the treatment effects of UPPP.
Study Aims
(Adults 18 and over)
- To determine whether UPPP improves sleep-related quality of life, measured in Functional Outcomes of Sleep Questionnaire
- To Establish whether UPPP affects sleep apnea-related symptoms: snoring, sleepiness or morning headache
- To validate the UPPP Prognostic Staging system (Friedman) for quality-of-life outcomes (measured with Functional Outcomes of Sleep Questionnaire) in UPPP patients
- To compare quality of life outcomes of UPPP alone versus UPPP with tongue procedure(s) in Friedman Stage II & III patients
Procedure
The surgeon recruits eligible UPPP patients (most will be eligible) and completes brief eligibilty and examination forms within 10 days before surgery. The surgeon has no further responsibilities after mailing the forms to the data coordinating center. The patient completes a baseline questionnaire and home blood pressure measurements within 10 days before surgery. The patient will receive a follow up questionnaire from the coordinating center 3 and 6 months after surgery.
Disease specific-quality of life will be measured with the Functional Outcomes of Sleep Questionnaire at enrollment and at three months post-operatively. Other measures include: global assesment in improvement in sleep apnea; disease-specific quality of life at six months post-procedure; and post-procedure change in secondary problems present at enrollment (sleepiness, snoring, headache, Nasal Obstruction and Septoplasty Effectiveness scale). Since many patients with sleep apnea have multiple sites of obstruction, subjects will be stratified by concomitant procedures with UPPP.
Notes
The SLEEP study is sponsored by the American Academy of Otolaryngology-Head and Neck Surgery Foundation and its National Center for the Promotion of Research in Otolaryngology, and supported by a generous grant from Schering-Plough. This research is coordinated by the Duke Clinical Research Institute at Duke University Medical Center in Durham, North Carolina.
The steering committee:
Edward M Weaver, MD, MPH, Co-PI
University of Washington
B. Tucker Woodson, MD, Co-PI
Medical College of Wisconsin
Michael G Stewart MD, MPH
Baylor College of Medicine
David Witsell, MD, MHS
Duke University
Maureen Hannley, PhD
AAO-HNSF
Timothy Smith, MD, MPH
Medical College of Wisconsin
Bevan Yueh, MD, MPH
University of Washington
Study Publication:
