RCT Between UPP and Controls in Adult OSA

NCT ID: NCT02522247

Last Updated: 2023-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Uvulopalatoplasty

Surgery with cold steel, single sutures of palate and tonsillar pillars including palatopharyngeal muscle

Group Type ACTIVE_COMPARATOR

UPP

Intervention Type PROCEDURE

surgery with cold steel in general anesthesia

Controls

Only waiting 6 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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UPP

surgery with cold steel in general anesthesia

Intervention Type PROCEDURE

Other Intervention Names

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Uvulopalatoplasty

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Danielle Friberg

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Tideholm, Md, PhD

Role: STUDY_DIRECTOR

ORL-dep, Karolinska University Hospital

Locations

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Orl dep, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2015/755-31/2B

Identifier Type: -

Identifier Source: org_study_id

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