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RCT Between UPP and Controls in Adult OSA

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ClinicalTrials.gov Identifier: NCT02522247
Recruitment Status : Withdrawn (No patients have been enrolled, maybe in the future the study will start up again)
First Posted : August 13, 2015
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Danielle Friberg, Karolinska University Hospital

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

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Procedure: UPP Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial Between Uvulopalatoplasty and Delayed Surgery (Controls)
Estimated Primary Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Uvulopalatoplasty
Surgery with cold steel, single sutures of palate and tonsillar pillars including palatopharyngeal muscle
Procedure: UPP
surgery with cold steel in general anesthesia
Other Name: Uvulopalatoplasty

No Intervention: Controls
Only waiting 6 months



Primary Outcome Measures :
  1. Polysomnography: group differences in changes of apnea-hypopnea index (AHI) [ Time Frame: 6 months ]
    compare the two groups of changes in number of apneas and hypopneas per sleep hour measured with inlab polysomnography, between baseline and follow-up


Secondary Outcome Measures :
  1. Questionnaire: group differences in changes of daytime sleepiness [ Time Frame: 6 months ]
    using validated questionnaire Epworth sleepiness scale measure changes between baseline and follow-up and compare the differences between groups

  2. Questionnaire: group differences in changes of general health [ Time Frame: 6 months ]
    using validated question

  3. Blood pressure: group differences in changes of blood pressure [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Polysomnography: changes of AHI between baseline and 4 years postoperatively [ Time Frame: 4 years ]
    The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.

  2. Questionnaire: changes of daytime sleepiness between baseline and 4 years postoperatively [ Time Frame: 4 years ]
    The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.

  3. Questionnaire: changes of general health between baseline and after 4 years postoperatively [ Time Frame: 4 years ]
    The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.

  4. Postoperative bleeding complications [ Time Frame: 6 months ]
    postop bleeding in milliliter

  5. Postoperative days at hospital [ Time Frame: 6 months ]
    report number of days at hospital postop



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02522247


Locations
Sweden
Orl dep, Karolinska University Hospital
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Study Director: Bo Tideholm, Md, PhD ORL-dep, Karolinska University Hospital

Responsible Party: Danielle Friberg, Associate Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02522247     History of Changes
Other Study ID Numbers: 2015/755-31/2B
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases