Trials Sponsors Conditions Drugs Pricing

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneaairway obstructionsleep-disordered breathing

Outcome Measures

Primary Outcomes (1)

sleep study result at 3-6 months; symptom changes at 3-6 months; pain at 0-3 weeks; post-operative complications at any time; post-operative anatomic result/appearance at 3-6 months
6-12mo

Secondary Outcomes (2)

Operative time
immediate
Procedure cost
immediate

Study Arms (3)

1

EXPERIMENTAL

suture palate after resection

Procedure: uvulopalatopharyngoplasty with or without sutures

2

EXPERIMENTAL

suture one side of palate afer resection

Procedure: uvulopalatopharyngoplasty with or without sutures

3

EXPERIMENTAL

no sutures in palate after resection

Procedure: uvulopalatopharyngoplasty with or without sutures

Interventions

uvulopalatopharyngoplasty with or without suturesProcedure

standard UPPP

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Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

sleep-study documented obstructive sleep apnea
sleep apnea refractory to non-surgical treatments including continuous positive airway pressure (CPAP)

Sponsors & Collaborators

Virginia Commonwealth University
Otherlead

Study Sites (1)

Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University

Richmond, Virginia, 23298-0146, United States

MeSH Terms

Conditions

Sleep Apnea, ObstructiveAirway ObstructionSleep Apnea Syndromes

Interventions

Sutures

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory Insufficiency

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices

Study Officials

Evan R Reiter, MD
Virginia Commonwealth University
PRINCIPAL INVESTIGATOR

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 20, 2005

Study Start

July 2004

Date type not reported

This date has not been verified as actual or estimated.

Study of Effects of Sutures on Results of Palate Surgery for Obstructive Sleep Apnea

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations