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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

Tracking Information
First Submitted Date  ICMJE September 15, 2015
First Posted Date  ICMJE October 6, 2015
Last Update Posted Date August 16, 2016
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
  • Snoring Intensity (measured in decibels) [ Time Frame: Three months ]
  • Snoring Index (number of snores per hour of sleep) [ Time Frame: Three months ]
  • Upper airway obstruction [ Time Frame: Three months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
  • Sleep quality evaluated with the Pittsburgh Sleep Quality Index [ Time Frame: Three months ]
  • Sleep quality of the patient room partner evaluated with the Pittsburgh Sleep Quality Index [ Time Frame: Three months ]
  • Sleepiness (evaluated with the Epworth Sleepiness Scale) [ Time Frame: Three months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Injection Snoreplasty and Oropharyngeal Exercises
Official Title  ICMJE Injection Snoreplasty and Oropharyngeal Exercises: Two Therapeutic Options in the Management of Snoring and Obstructive Sleep Apnea Syndrome.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Snoring
  • Obstructive Sleep Apnea Syndrome
Intervention  ICMJE
  • 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.
  • Other: Oropharyngeal Exercises
    Myofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Injection Snoreplasty
  • 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.
    Intervention: Other: Oropharyngeal Exercises
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 2, 2015)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02568761
Other Study ID Numbers  ICMJE 14-0637
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michelle Lavinsky Hospital de Clínicas de Porto Alegre
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP