Injection Snoreplasty and Oropharyngeal Exercises

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

Injection Snoreplasty and Oropharyngeal Exercises: Two Therapeutic Options in the Management of Snoring and Obstructive Sleep Apnea Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02568761
• Other study ID #: 14-0637
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2015
• Last updated: August 15, 2016
• Start date: August 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Caroline P Royer
• Phone: 55 51 3359 8000
• Email: carol_persch[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Snoring
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Brazil	Serviço de Otorrinolaringologia do Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Snoring Intensity (measured in decibels)		Three months	No
Primary	Snoring Index (number of snores per hour of sleep)		Three months	No
Primary	Upper airway obstruction		Three months	No
Secondary	Sleep quality evaluated with the Pittsburgh Sleep Quality Index		Three months	No
Secondary	Sleep quality of the patient room partner evaluated with the Pittsburgh Sleep Quality Index		Three months	No
Secondary	Sleepiness (evaluated with the Epworth Sleepiness Scale)		Three months	No