Injection Snoreplasty and Oropharyngeal Exercises

NCT02568761 | Unknown

• 1 other identifier: 14-0637
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized single blind clinical trial, with a larger sample size than previous studies , to evaluate the effectiveness of injection snoreplasty in the treatment of patients with snoring and obstructive sleep apnea/hypopnea syndrome (OSAHS) compared to oropharyngeal exercises, a low cost therapeutic modality.

Conditions

Snoring; Obstructive Sleep Apnea Syndrome

Keywords

Snoring; Sleep apnea; Obstructive sleep apnea; Speech therapy; Injection snoreplasty; Ethanol; Oropharyngeal exercises

Outcome Measures

Primary Outcomes (3)

• Snoring Intensity (measured in decibels)

  Three months

• Snoring Index (number of snores per hour of sleep)

  Three months

• Upper airway obstruction

  Three months

Secondary Outcomes (3)

• Sleep quality evaluated with the Pittsburgh Sleep Quality Index

  Three months

• Sleep quality of the patient room partner evaluated with the Pittsburgh Sleep Quality Index

  Three months

• Sleepiness (evaluated with the Epworth Sleepiness Scale)

  Three months

Study Arms (2)

Injection snoreplasty

ACTIVE COMPARATOR

Nonsurgical treatment involving the injection of 1.5 ml of 50% ethanol (1 ml of 99.5% ethanol diluted in 1ml of 2% xylocaine) into the upper palate. 0.5 ml of the solution will be implemented in three different regions of the submucosal layer of the soft palate, one median and two paramedians.

Procedure: Injection Snoreplasty

Oropharyngeal Exercises

ACTIVE COMPARATOR

Weekly sessions of myofunctional exercises under the supervision of a qualified professional, lasting about 30 minutes each, combined with daily exercises without supervision for a period of three months.

Other: Oropharyngeal Exercises

Interventions

Injection Snoreplasty PROCEDURE

Nonsurgical treatment involving the injection of 1.5 ml of 50% ethanol (1 ml of 99.5% ethanol diluted in 1ml of 2% xylocaine) into the upper palate.

Injection snoreplasty

Oropharyngeal Exercises OTHER

Myofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue.

Oropharyngeal Exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient without specific prior treatment for snoring and/or apnea.

You may not qualify if:

• Prior pharyngeal surgery to treat snoring or obstructive sleep apnea/hypopnea syndrome (OSAHS).
• Body mass index above 35Kg / m2.
• Nasal or pharyngeal anatomical obstruction higher than 50% of the light.
• Craniofacial deformity.
• Pregnancy.
• Major illnesses associated.
• Ethanol allergy history.
• Absence of a companion to observe the intensity of snoring.
• Patients with no ability to understand the issues (understanding of the proposed procedure and consent form).

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Serviço de Otorrinolaringologia do Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

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MeSH Terms

Conditions

Snoring; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Communication Disorders

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Michelle Lavinsky

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline P Royer

CONTACT

55 51 3359 8000; carol_persch@hotmail.com

Simone C Fagondes

CONTACT

55 51 3359 8000

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: October 6, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

BR (1)