RCT Between UPP and Controls in Adult OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

Randomized Control Trial Between Uvulopalatoplasty and Delayed Surgery (Controls)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02522247
• Other study ID #: 2015/755-31/2B
• Status: Withdrawn
• Phase: N/A

Study information

• Verified date: March 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effect of uvulopalatoplasty with no treatment in treating adult OSA.

Description:

Two arms: the intervention group undergo uvulopalatoplasty one month after baseline polysomnography (PSG1) and a PSG2 6 months after surgery . The control group perform PSG 1 and are then waiting 6 months, thereafter undergo PSG2, then surgery and PSG3 6 months after surgery. All patients are followed for four years with PSG. Patients fill in questionnaires at PSG sessions, and blood pressure control the morning after.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• AHI of 15 or more
• Friedmans stage I+II
• Tonsil size 0-1
• BMI<34
• ESS värde >7
• Failed treatment with CPAP and mandibular device

Exclusion Criteria:

• Severe cardiovascular or neurological disease
• ASA IV
• Not interested in surgical treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Procedure:
• UPP
surgery with cold steel in general anesthesia

Locations

Country	Name	City	State
Sweden	Orl dep, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Polysomnography: changes of AHI between baseline and 4 years postoperatively	The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.	4 years
Other	Questionnaire: changes of daytime sleepiness between baseline and 4 years postoperatively	The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.	4 years
Other	Questionnaire: changes of general health between baseline and after 4 years postoperatively	The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.	4 years
Other	Postoperative bleeding complications	postop bleeding in milliliter	6 months
Other	Postoperative days at hospital	report number of days at hospital postop	6 months
Primary	Polysomnography: group differences in changes of apnea-hypopnea index (AHI)	compare the two groups of changes in number of apneas and hypopneas per sleep hour measured with inlab polysomnography, between baseline and follow-up	6 months
Secondary	Questionnaire: group differences in changes of daytime sleepiness	using validated questionnaire Epworth sleepiness scale measure changes between baseline and follow-up and compare the differences between groups	6 months
Secondary	Questionnaire: group differences in changes of general health	using validated question	6 months
Secondary	Blood pressure: group differences in changes of blood pressure		6 months