SnoringNCT02568761
Injection Snoreplasty and Oropharyngeal Exercises
A study testing Injection Snoreplasty and Oropharyngeal Exercises in people with Snoring and Obstructive Sleep Apnea Syndrome, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snoring, Obstructive Sleep Apnea Syndrome
- What is being tested?
- Injection Snoreplasty and Oropharyngeal Exercises
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Simone C Fagondes contact
Brazil1 site, 1 recruiting
- Recruiting
Serviço de Otorrinolaringologia do Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Caroline P Royer, 55 51 3359-8000 ext. 8349, carol_persch@hotmail.com
Simone C Fagondes, 55 51 3359-8000 ext. 8241
About this study
Official title: Injection Snoreplasty and Oropharyngeal Exercises: Two Therapeutic Options in the Management of Snoring and Obstructive Sleep Apnea Syndrome.
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.
Read the 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.
- Conditions
- Snoring, Obstructive Sleep Apnea Syndrome
- Being tested
- Injection Snoreplasty, Oropharyngeal Exercises
- Keywords
- Snoring, Sleep apnea, Obstructive sleep apnea, Speech therapy, Injection snoreplasty, Ethanol, Oropharyngeal exercises
- Medical subject headings
- Snoring, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection SnoreplastyProcedure or surgery
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.
Oropharyngeal ExercisesOther
Myofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Oropharyngeal Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Snoring Intensity (measured in decibels)
Measured: Three months
Snoring Index (number of snores per hour of sleep)
Measured: Three months
Upper airway obstruction
Measured: Three months
Secondary outcomes (3)
Sleep quality evaluated with the Pittsburgh Sleep Quality Index
Measured: Three months
Sleep quality of the patient room partner evaluated with the Pittsburgh Sleep Quality Index
Measured: Three months
Sleepiness (evaluated with the Epworth Sleepiness Scale)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for SnoringStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Lavinsky, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568761
- Sponsor's protocol ID
- 14-0637
- Status last verified
- Aug 2016
- First submitted
- 15 Sep 2015
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Siegel JM. Sleep viewed as a state of adaptive inactivity. Nat Rev Neurosci. 2009 Oct;10(10):747-53. doi: 10.1038/nrn2697. Epub 2009 Aug 5.
PubMed 19654581Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.
PubMed 10450601Reimer MA, Flemons WW. Quality of life in sleep disorders. Sleep Med Rev. 2003 Aug;7(4):335-49. doi: 10.1053/smrv.2001.0220.
PubMed 14505600Drazen JM. Sleep apnea syndrome. N Engl J Med. 2002 Feb 7;346(6):390. doi: 10.1056/NEJM200202073460602. No abstract available.
PubMed 11832526Chung F, Elsaid H. Screening for obstructive sleep apnea before surgery: why is it important? Curr Opin Anaesthesiol. 2009 Jun;22(3):405-11. doi: 10.1097/ACO.0b013e32832a96e2.
PubMed 19412094Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
PubMed 18431116Vrints H, Shivalkar B, Hilde H, Vanderveken OM, Hamans E, Van de Heyning P, De Backer W, Verbraecken J. Cardiovascular mechanisms and consequences of obstructive sleep apnoea. Acta Clin Belg. 2013 May-Jun;68(3):169-78. doi: 10.2143/ACB.2981.
PubMed 24156215Phillipson EA. Sleep apnea--a major public health problem. N Engl J Med. 1993 Apr 29;328(17):1271-3. doi: 10.1056/NEJM199304293281712. No abstract available.
PubMed 8464440Ellen RL, Marshall SC, Palayew M, Molnar FJ, Wilson KG, Man-Son-Hing M. Systematic review of motor vehicle crash risk in persons with sleep apnea. J Clin Sleep Med. 2006 Apr 15;2(2):193-200.
PubMed 17557495Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
PubMed 11991871Hoffstein V, Szalai JP. Predictive value of clinical features in diagnosing obstructive sleep apnea. Sleep. 1993 Feb;16(2):118-22.
PubMed 8446830Zancanella E, Haddad FM, Oliveira LA, Nakasato A, Duarte BB, Soares CF, Cahali MB, Eckeli A, Caramelli B, Drager LF, Ramos BD, Nobrega M, Fagondes SC, Andrada NC; Associacao Brasileira de Otorrinolaringologia e Cirurgia Cervico-Facial; Academia Brasileira de Neurologia; Sociedade Brasileira de Cardiologia; Sociedade Brasileira de Pediatria; Sociedade Brasileira de Pneumologia e Tisiologia. Obstructive sleep apnea and primary snoring: diagnosis. Braz J Otorhinolaryngol. 2014 Jan-Feb;80(1 Suppl 1):S1-16. No abstract available. English, Portuguese.
PubMed 24838760Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
PubMed 8464434Koskenvuo M, Kaprio J, Telakivi T, Partinen M, Heikkila K, Sarna S. Snoring as a risk factor for ischaemic heart disease and stroke in men. Br Med J (Clin Res Ed). 1987 Jan 3;294(6563):16-9. doi: 10.1136/bmj.294.6563.16.
PubMed 3101779Schmidt-Nowara WW, Coultas DB, Wiggins C, Skipper BE, Samet JM. Snoring in a Hispanic-American population. Risk factors and association with hypertension and other morbidity. Arch Intern Med. 1990 Mar;150(3):597-601. doi: 10.1001/archinte.150.3.597.
PubMed 2310278
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Snoreplasty and Oropharyngeal Exercises: Two Therapeutic Options in the Management of Snoring and Obstructive Sleep Apnea Syndrome.
- ClinicalTrials.gov ID
- NCT02568761
- Acronym / sponsor ID
- 14-0637
- Conditions
- Snoring, Obstructive Sleep Apnea Syndrome
- Keywords
- Snoring, Sleep apnea, Obstructive sleep apnea, Speech therapy, Injection snoreplasty, Ethanol, Oropharyngeal exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection snoreplasty | Active comparator | Procedure: Injection SnoreplastyNonsurgical 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. |
| Oropharyngeal Exercises | Active comparator | Other: Oropharyngeal ExercisesWeekly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection SnoreplastyNonsurgical 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. | Procedure or surgery | Injection snoreplasty |
| Oropharyngeal ExercisesMyofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue. | Other | Oropharyngeal Exercises |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Background: PubMed 19654581Siegel JM. Sleep viewed as a state of adaptive inactivity. Nat Rev Neurosci. 2009 Oct;10(10):747-53. doi: 10.1038/nrn2697. Epub 2009 Aug 5.
- Background: PubMed 10450601Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.
- Background: PubMed 14505600Reimer MA, Flemons WW. Quality of life in sleep disorders. Sleep Med Rev. 2003 Aug;7(4):335-49. doi: 10.1053/smrv.2001.0220.
- Background: PubMed 11832526Drazen JM. Sleep apnea syndrome. N Engl J Med. 2002 Feb 7;346(6):390. doi: 10.1056/NEJM200202073460602. No abstract available.
- Background: PubMed 19412094Chung F, Elsaid H. Screening for obstructive sleep apnea before surgery: why is it important? Curr Opin Anaesthesiol. 2009 Jun;22(3):405-11. doi: 10.1097/ACO.0b013e32832a96e2.
- Background: PubMed 18431116Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
- Background: PubMed 24156215Vrints H, Shivalkar B, Hilde H, Vanderveken OM, Hamans E, Van de Heyning P, De Backer W, Verbraecken J. Cardiovascular mechanisms and consequences of obstructive sleep apnoea. Acta Clin Belg. 2013 May-Jun;68(3):169-78. doi: 10.2143/ACB.2981.
- Background: PubMed 8464440Phillipson EA. Sleep apnea--a major public health problem. N Engl J Med. 1993 Apr 29;328(17):1271-3. doi: 10.1056/NEJM199304293281712. No abstract available.
- Background: PubMed 17557495Ellen RL, Marshall SC, Palayew M, Molnar FJ, Wilson KG, Man-Son-Hing M. Systematic review of motor vehicle crash risk in persons with sleep apnea. J Clin Sleep Med. 2006 Apr 15;2(2):193-200.
- Background: PubMed 11991871Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
- Background: PubMed 8446830Hoffstein V, Szalai JP. Predictive value of clinical features in diagnosing obstructive sleep apnea. Sleep. 1993 Feb;16(2):118-22.
- Background: PubMed 24838760Zancanella E, Haddad FM, Oliveira LA, Nakasato A, Duarte BB, Soares CF, Cahali MB, Eckeli A, Caramelli B, Drager LF, Ramos BD, Nobrega M, Fagondes SC, Andrada NC; Associacao Brasileira de Otorrinolaringologia e Cirurgia Cervico-Facial; Academia Brasileira de Neurologia; Sociedade Brasileira de Cardiologia; Sociedade Brasileira de Pediatria; Sociedade Brasileira de Pneumologia e Tisiologia. Obstructive sleep apnea and primary snoring: diagnosis. Braz J Otorhinolaryngol. 2014 Jan-Feb;80(1 Suppl 1):S1-16. No abstract available. English, Portuguese.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone C Fagondes contact
Michelle Lavinsky principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection Snoreplasty and Oropharyngeal Exercises in people with Snoring and Obstructive Sleep Apnea Syndrome, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline P Royer (55 51 3359 8000 ext. 8314, carol_persch@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snoring Intensity (measured in decibels) (time frame: Three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02568761, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.