Obstructive Sleep Apnea Syndrome
Conditions
Brief summary
Hypothesis:Pharyngeal surgery (UPPP) reduces significantly the nightly respiratory breathing pauses (apnoeas-hypopnoeas) and improves the daytime symptoms compared to expectancy for 6 months in patients with OSAS. Background: Obstructive sleep apnea syndrome (OSAS) is associated with an increased risk of poor sleep quality, excessive daytime sleepiness and prolonged reaction time, which can elevate the risk for traffic accidents. Increased morbidity and three to four times increased mortality in these patients are well documented, mainly in the cardiovascular field. Pharyngeal surgery, i.e. uvulopalatopharyngoplasty (UPPP) opens up the airway and was the predominant treatment for OSAS worldwide before continuous positive airway pressure (CPAP) devices became widely available in the 1990s. Since then, the main treatment for OSAS has been CPAP, but an increasing number of patients are also treated with mandibular retaining device (MRD). UPPP as treatment for OSAS has been performed for 30 years. The evidence-grade for the efficacy has so far been very low, and the side-effects and complication rate has raised the question whether there is a place for surgical treatment of OSAS. However, the compliance for CPAP and dental devices are quite low (50-60%), leaving a lot of patients untreated if surgery is not offered. RCT UPPP is still missing and called for.
Interventions
PROCEDUREUvulopalatopharyngoplasty
Uvulopalatopharyngoplasty: Resection of the soft palate 3 mm and tonsillectomy, amputation of the uvula to approx 1 cm, single sutures of the posterior pillar to the anterior pillar and of the soft palate.
Sponsors
Karolinska Institutet
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ApnéHypopnéIndex, AHI \>14,9 Daytime sleepiness w Epworth sleepiness scale, ESS\> 7 Sleepy during daytime 3-5 times per week or more BodyMassIndex, BMI \< 36,0 Friedman staging system of tonsil size and tongue: i and II Patients w Friedman stage I and BMI \< 30,0 could be directly included if patient positive and no contra-indications for surgery. All others should be failure of CPAP and MRD before inclusion.
Exclusion criteria
Other OSAS treatment during study, i.e., patient is clinically severely deteriorated. Negative to surgery Night-shift worker Friedman stage III or IV Morbid obesity BMI \>35,9 Severe psychological or neurological disease ASA class \>3 Severe lung- or heart disease (not applicable for hypertension, nor stroke or MI more than after 2 years). Insufficient knowledge in Swedish language (important for filling in questionnaires) Dangerous in traffic while driving Severe nasal congestion (can be included after successful treatment) Previous tonsillectomy \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in apnea-hypopnea index | 6 months and 2 years | Apnea-hypopnea index (AHI) is the number of apneas or hypopneas per sleep hour. Polysomnography (PSG) is the Golden standard to use when measuring the AHI. PSG is the method we are using |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Epworth sleepiness scale | 6 months and 2 years | Epworth sleepiness scale is a validated questionnaire. It consists of eight questions concerning the patients´ ability to fall asleep in different situations. The total sum is 24. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Oxygen desaturation index | 6 months and 2 years | Oxygen desaturation index (ODI) is the number of oxygen desaturations of 3 % or more per sleep hour. |
| changes in blood samples | 6 months 2 years | Hb, LPK, CRP, cortisol, TSH, T4, ASAT, ALAT, ALP, γ-GT, CDT, Leptin/ghrelin, fB-Glucose, f-insulin, HDL, LDL, Cholesterol, Triglycerides, TNF-α, IL-1, IL-6 |
| changes in score of SF 36 quality of life questionnaire | 6 months and 2 years | QoL SF 36 validated questionnaire |
| changes in blood pressure | 6 months and 2 years | systolic and diastolic morning pressure from arm |
| changes in vigilance | 6 months and 2 years | modified Osler test |
| number of patients with serious complications from surgery | 6 months | — |
| number of patients with side-effects from surgery | 6 months and 2 years | answers from a local questionnaire regaring pharyngeal side-effects |
| Changes in score of FOSQ questionnaire | 6 months and 2 years | Validated questionnaire designed for patients with obstructive sleep apnea syndrome |
| identifying success factors for outcome of surgical intervention | 6 months 2 years | Correlate for example tonsil size and tongue position (stageing system) with changes in AHI |
| changes in arousal index | 6 months and 2 years | Polysomnographic results |
| changes in lowest oxygen saturation during sleep | 6 months 2 years | Polysomnographic results |
| changes in ODI during REM sleep | 6 months 2 years | Polysomnographic results |
| changes in ODI in supine position | 6 months 2 years | Polysomnographic results |
| changes in time in supine position | 6 months and 2 years | Polysomnographic results |
| changes in Body Mass Index | 6 months and 2 years | — |
| changes in RERA index | 6 months and 2 years | Polysomnographic results, RERA are the respiratory effort related arousals during sleep |
| changes in mean length apneas and hypopneas | 6 months and 2 years | Polysomnographic results |
| changes in AHI supine position | 6 months 2 years | Polysomnographic results |
| changes in AHI in REM | 6 months and 2 years | Polysomnographic results |
| changes in total sleep time | 6 months and 2 years | Polysomnograåhic results |
| changes in RDI | 6 months and 2 years | Polysomnographic results; RDI is the sum of AHI and RERA index |
Countries
Sweden
Outcome results
None listed