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Injection Snoreplasty and Oropharyngeal Exercises

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ClinicalTrials.gov Identifier: NCT02568761
Recruitment Status : Unknown
Verified August 2016 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : October 6, 2015
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Snoring Obstructive Sleep Apnea Syndrome Procedure: Injection Snoreplasty Other: Oropharyngeal Exercises Not Applicable

Detailed Description:

34 patients will be randomly allocated into two groups. One group will be submitted to injection snoreplasty and another group will be submitted to daily sessions of oropharyngeal exercises. Researchers involved in interventions will not participate in the outcomes evaluation and researchers responsible for the assessment of outcomes will be blinded to the tested therapeutic modalities.

All patients will be evaluated at a pre-intervention visit, when will be collected objective data and carried out a complete otorhinolaryngological exam. Patients will fill validated specific questionnaires for evaluation of snoring, apnea, daytime sleepiness, fatigue, presence of systemic arterial hypertension and sleep quality. The quality of sleep of the patients bedroom companions will be also evaluated. Patients will be randomized only after these evaluations.

All patients included in the study will be submitted to a portable sleep study. Simultaneously, the objective assessment of snoring will be held, covering the analysis of snoring intensity (measured in decibels) and the snoring index (number of snores per hour of sleep).

Patients allocated to group A will receive injection snoreplasty. Patient returns will be weekly, until the complete healing of the palate. After four weeks of treatment, the bedroom companion will be asked about whether the snoring remains a problem, and if so, the procedure is repeated, with each patient receiving up to three applications. At the end of three months, all evaluations will be repeated and the data obtained will be compared to baseline data.

Patients allocated at group B will be evaluated by a speech therapist. Patients will undergo weekly oropharyngeal exercises sessions under supervision, lasting about 30 minutes each, and will be instructed to perform the exercises daily at home, for a period of three months. At the end of this period, patients will be re-evaluated and the initial data will be compared to the obtained final data.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Injection Snoreplasty and Oropharyngeal Exercises: Two Therapeutic Options in the Management of Snoring and Obstructive Sleep Apnea Syndrome.
Study Start Date : August 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Injection snoreplasty
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
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.

Active Comparator: Oropharyngeal Exercises
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
Myofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue.




Primary Outcome Measures :
  1. Snoring Intensity (measured in decibels) [ Time Frame: Three months ]
  2. Snoring Index (number of snores per hour of sleep) [ Time Frame: Three months ]
  3. Upper airway obstruction [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. Sleep quality evaluated with the Pittsburgh Sleep Quality Index [ Time Frame: Three months ]
  2. Sleep quality of the patient room partner evaluated with the Pittsburgh Sleep Quality Index [ Time Frame: Three months ]
  3. Sleepiness (evaluated with the Epworth Sleepiness Scale) [ Time Frame: Three months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients evaluated at the Snoring and Apnea Ambulatory of Hospital de Clinicas de Porto Alegre with clinical complaints related to snoring and sleep apnea with polysomnography held within 90 days before the inclusion, evidencing index of apnea/hypopnea from 0 to 30 events per hour of sleep (snoring , mild and moderate apnea), without showing desaturation below 90% for time periods longer than 60 minutes.
  • Patient without specific prior treatment for snoring and/or apnea.

Exclusion Criteria:

  • 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).

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): NCT02568761


Contacts
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Contact: Caroline P Royer 55 51 3359 8000 ext 8314 carol_persch@hotmail.com
Contact: Simone C Fagondes 55 51 3359 8000 ext 8241

Locations
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Brazil
Serviço de Otorrinolaringologia do Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Caroline P Royer    55 51 3359-8000 ext 8349    carol_persch@hotmail.com   
Contact: Simone C Fagondes    55 51 3359-8000 ext 8241      
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Michelle Lavinsky Hospital de Clínicas de Porto Alegre
Publications:
STRAUSS JF. A new approach to the treatment of snoring: A preliminary report. Arch Otolaryngol.1943 Sep;38(3):225-9.
Lorenzetti FTM. Injeção roncoplástica: comparação entre etanol 50% e oleato de etanolamina 5% no tratamento do ronco [Internet] [text]. Universidade de São Paulo; 2011. At http://www.teses.usp.br/teses/disponiveis/5/5143/tde-20072011-151743/
Guimarães KCC. Efeitos dos exercícios orofaríngeos em pacientes com apnéia obstrutiva do sono moderada: estudo controlado e randomizado [Internet] [text]. Universidade de São Paulo; 2008. At: http://www.teses.usp.br/teses/disponiveis/5/5150/tde-22082008-170703/

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02568761    
Other Study ID Numbers: 14-0637
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
Snoring
Sleep apnea
Obstructive sleep apnea
Speech therapy
Injection snoreplasty
Ethanol
Oropharyngeal exercises
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Snoring
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds