Sleep Apnea, ObstructiveNCT03169491
Effect of CPAP and Adenotonsillectomy in Upper Airway Volume of Children With OSAS
A study testing Continuous positive airway pressure (CPAP) in people with Sleep Apnea, Obstructive and Child, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
Trial summary
Obstructive sleep apnea syndrome (OSAS) in children has high prevalence and severe complications, and its first line of treatment (adenotonsillectomy) has risk of complications. Even though the use of presurgical CPAP seems logical due to its effects in adults, it must be studied in children due to the different… Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Child, Continuous Positive Airway Pressure
- What is being tested?
- Continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- 4 Jul 2016to 30 Nov 2019
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 4 and 14 years old. Both genders. Diagnosis of OSAS based on sleep study (respiratory polygraphy or polysomnography).
- Surgical treatment planned by the ORL department of the Institute of Respiratory Diseases of Mexico.
- Residents of the Metropolitan Area of Mexico City Parents and child accept to particpate in the study, singning informed consent and assent.
Who cannot join
- Previous surgery in upper airway. Craneofacial malformation. Previous use of CPAP. Syndromatic patient.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional Enfermedades Respiratorias
Mexico City, 14080
Angélica M Portillo-Vásquez, MD, +525554871700 ext. 5242, ampvs1986@gmail.com
Alejandra Castillo, Tc, +525554871700 ext. 5242, ale_k_stillo@hotmail.com
About this study
Official title: Caliber of Upper Airway Measured by Acoustic Pharyngometry in Children With Obstructive Sleep Apnea Before and After the Use of Presurgical CPAP and After Adentonsillectomy, and Their Relation With Surgical Complications and Residual Apneas
Obstructive sleep apnea syndrome (OSAS) in children has high prevalence and severe complications, and its first line of treatment (adenotonsillectomy) has risk of complications. Even though the use of presurgical CPAP seems logical due to its effects in adults, it must be studied in children due to the different physiopathology and adherence. One non-invasive way of study the effect is via acoustic pharyngometry, which can measure the anatomical site of obstruction. The post-surgical anatomical changes could correlate with a persistent OSAS, which would be helpful in selecting those patients who require a post surgical sleep study. The main goal of the study is to cuantify the changes in the oropharyngeal volume via acoustic pahryngometry after CPAP use, and also the changes after adentonsillectomy in children.
Read the detailed description
The obstructive sleep apnea syndrome (OSAS) is defined as recurrent events of obstruction of the upper airway (with alteration of normal oxygenation, ventilation or sleep pattern). In children originates complications such as cognitive, cardiovascular and metabolic disorders and growth failure, which make its management imperative. It has a reported prevalence between 1 and 5%, highest between 2 and 8 years old, due to tonsil and adenoid hypertrophy, which causes obstruction of the upper airway, unlike the fat deposits of adults. This physiopathological cause of obstruction makes adenotonsillectomy the first line of management. This is a secure procedure, which still has an incidence of complications of 19%, (9.5% respiratory and 2.4% secondary bleeding). Those with OSAS present complications more frequently than those without7. Even though the surgery is considered succesful, up to 21.6% of those treated present persistence of the disease. Based on these results the American Academy of Pediatrics recommends considering polysomnography after surgery in those patients with high risk of persistence, such as obese children.
The continuous positive airway pressure (CPAP) device provides a continuous pressure through a mask, acting as a pneumatic ferule which keeps the upper airway permeable; with a lower possibility of obstruction. The adherence of pediatric patients to CPAP has been reported between 6 and 65% (which is one of the reasons it's not considered the first line treatment), with an use of 2.1 to 8.2 hours per night, and an AIH (apnea-hypopnea index) between 2 and 6 per hour. In adult patients, a reduction in trans and post-surgical risk has been found, and therefore its pre-surgical use is recommended. In children it is one of the strategies used to reduce surgical risk in OSAS, even though its use is not recommended in any of the main clinical guides of management of children with OSAS. Its use has been described in children with severe illness, and in other studies it was used in 18% of patients, but its real effect in the probable complications has not been prospectively studied.
In adult subjects, inflammation of upper airway has been reported, and it could play a role in the physiopathology of OSAS, with changes in the minimal sectional area and pharyngeal volume measured by MRI after use for 4 to 6 weeks of CPAP use. Albeit the physiopathology is not completely understood, it could be a consequence of the mechanical stress associated to obstruction of airflow, with the repeated trauma related with snore, jointly with the upper airway vibration and the suction from the collapse during the apneas the causes. CPAP eliminates respiratory events, which could cause a reduction in edema and inflammation.
Acoustic pharyngometry is a non-invasive method which uses sound reflection to quickly measure the sectional area of the upper airway in function of the distance from the oral aperture. It can be adapted to its use in children, obtaining highly reproducible results, even though it is limited to those who can follow instructions. In adults a difference was found between the minimum oropharyngeal area and the mean area after 1 week of CPAP use, but not between 1 week and 6 months of use, with a return to basal after a 1 week of nonuse. In our center change in volume and transversal oropharyngeal area have been found with acoustic pharyngometry since the second week of use of CPAP, of 5% at 2 weeks and 6% at 4 weeks. In children changes after surgery have been found, with increase in the minimal sectional area and oropharyngeal volume, even though its correlation with persistent OSAS has not been studied.
In order to study the changes in the upper airway after CPAP, acoustic pharyngometry will be performed before and after CPAP use, and 3 months after adenotonsillectomy to determinate the relation to persistent OSAS. The presurgical CPAP will be randomized in those children with diagnosis of mild to moderate OSAS.
- Conditions
- Sleep Apnea, Obstructive, Child, Continuous Positive Airway Pressure, Adenoidectomy, Tonsillectomy
- Being tested
- Continuous positive airway pressure (CPAP)
- Keywords
- Sleep Apnea, Obstructive, Child, Continuous Positive Airway Pressure, Perioperative management, Adenotonsillectomy, Acoustic pharyngometry
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP)Device
CPAP dispositives will be used by the children in the study every night for two weeks. Devices AutoSet Spirit from ResMed.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic | Experimental | Continuous positive airway pressure (CPAP) with automatic pressure from 4 to 15 cmH2O every night for one week, afterwards use of CPAP at the P90 of pressure determinated during automatic use for one week, via oronasal interface. Receives: Device: Continuous positive airway pressure (CPAP) |
| Suboptimal | Sham comparator | Continuous positive airway pressure (CPAP) every night for two weeks at fixed pressure of 4 cmH2O, via oronasal interface. Receives: Device: Continuous positive airway pressure (CPAP) |
| Severe OSAS | Other | Continuous positive airway pressure (CPAP) with automatic pressure from 4 to 15 cmH2O every night for one week, afterwards use of CPAP at the P90 of pressure determinated during automatic use for one week, via oronasal interface. Receives: Device: Continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal volume postCPAP.
Upper airway volume as measured by acoustic pharyngometry.
Measured: After two weeks of CPAP use.
Secondary outcomes (6)
Oropharyngeal volume post-surgery
Upper airway volume as measured by acoustic pharyngometry.
Measured: Three months after adenotonsillectomy.
OSA-18.
Score in que quality of life questionnaire OSA-18.
Measured: After two weeks of CPAP use.
OSA-18.
Score in que quality of life questionnaire OSA-18.
Measured: Three months after adenotonsillectomy.
Pediatric Sleep Questionnaire.
Symptoms as described in the pediatric sleep questionnaire.
Measured: After two weeks of CPAP use.
Pediatric Sleep Questionnaire.
Symptoms as described in the pediatric sleep questionnaire.
Measured: Three months after adentonsillectomy.
Surgical complications.
Complications during or after the surgical procedure, as determined by checklist.
Measured: During and one month after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start4 Jul 2016
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All recruited children with diagnosis of mild to moderate OSAS will be randomized to suboptimal (CPAP at 4 cmH2O) or therapeutical (CPAP auto from 4 to 15 cmH2O) arms, from a predetermined list in two groups of 50, blocks of 10 patients. All patients with diagnosis of severe OSAS will receive therapeutic pressure, and are considered as part of a third arm not included in the sample size.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Enfermedades Respiratorias
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Angélica Margarita Portillo Vásquez, Instituto Nacional de Enfermedades Respiratorias
- Investigators
- José Rogelio Pérez-Padilla, MD, Study director, Instituto Nacional Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169491
- Sponsor's protocol ID
- C12-16
- Status last verified
- Jul 2018
- First submitted
- 25 May 2017
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data from the study could be provided if solicited at the main author's e-mail adress.
Publications
Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5.
PubMed 26541535De Luca Canto G, Pacheco-Pereira C, Aydinoz S, Bhattacharjee R, Tan HL, Kheirandish-Gozal L, Flores-Mir C, Gozal D. Adenotonsillectomy Complications: A Meta-analysis. Pediatrics. 2015 Oct;136(4):702-18. doi: 10.1542/peds.2015-1283. Epub 2015 Sep 21.
PubMed 26391937Kang KT, Hsu WC. Adenotonsillectomy outcomes in treatment of obstructive sleep apnea in children: a multicenter retrospective study. Am J Respir Crit Care Med. 2012 Nov 1;186(9):927; author reply 927-8. doi: 10.1164/ajrccm.186.9.927. No abstract available.
PubMed 23118085Castorena-Maldonado A, Torre-Bouscoulet L, Meza-Vargas S, Vazquez-Garcia JC, Lopez-Escarcega E, Perez-Padilla R. Preoperative continuous positive airway pressure compliance in children with obstructive sleep apnea syndrome: assessed by a simplified approach. Int J Pediatr Otorhinolaryngol. 2008 Dec;72(12):1795-800. doi: 10.1016/j.ijporl.2008.08.016. Epub 2008 Oct 4.
PubMed 18835648Monahan KJ, Larkin EK, Rosen CL, Graham G, Redline S. Utility of noninvasive pharyngometry in epidemiologic studies of childhood sleep-disordered breathing. Am J Respir Crit Care Med. 2002 Jun 1;165(11):1499-503. doi: 10.1164/rccm.200111-061OC.
PubMed 12045123Corda L, Redolfi S, Montemurro LT, La Piana GE, Bertella E, Tantucci C. Short- and long-term effects of CPAP on upper airway anatomy and collapsibility in OSAH. Sleep Breath. 2009 May;13(2):187-93. doi: 10.1007/s11325-008-0219-1. Epub 2008 Sep 25.
PubMed 18815823
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caliber of Upper Airway Measured by Acoustic Pharyngometry in Children With Obstructive Sleep Apnea Before and After the Use of Presurgical CPAP and After Adentonsillectomy, and Their Relation With Surgical Complications and Residual Apneas
- ClinicalTrials.gov ID
- NCT03169491
- Acronym / sponsor ID
- C12-16
- Conditions
- Sleep Apnea, Obstructive, Child, Continuous Positive Airway Pressure, Adenoidectomy, Tonsillectomy
- Keywords
- Sleep Apnea, Obstructive, Child, Continuous Positive Airway Pressure, Perioperative management, Adenotonsillectomy, Acoustic pharyngometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Instituto Nacional de Enfermedades RespiratoriasOther government
- Study start
- 4 Jul 2016 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 30 May 2017 (actual)
- 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.
Obstructive sleep apnea syndrome (OSAS) in children has high prevalence and severe complications, and its first line of treatment (adenotonsillectomy) has risk of complications. Even though the use of presurgical CPAP seems logical due to its effects in adults, it must be studied in children due to the different physiopathology and adherence. One non-invasive way of study the effect is via acoustic pharyngometry, which can measure the anatomical site of obstruction. The post-surgical anatomical changes could correlate with a persistent OSAS, which would be helpful in selecting those patients who require a post surgical sleep study. The main goal of the study is to cuantify the changes in the oropharyngeal volume via acoustic pahryngometry after CPAP use, and also the changes after adentonsillectomy in children.
Detailed description
The obstructive sleep apnea syndrome (OSAS) is defined as recurrent events of obstruction of the upper airway (with alteration of normal oxygenation, ventilation or sleep pattern). In children originates complications such as cognitive, cardiovascular and metabolic disorders and growth failure, which make its management imperative. It has a reported prevalence between 1 and 5%, highest between 2 and 8 years old, due to tonsil and adenoid hypertrophy, which causes obstruction of the upper airway, unlike the fat deposits of adults. This physiopathological cause of obstruction makes adenotonsillectomy the first line of management. This is a secure procedure, which still has an incidence of complications of 19%, (9.5% respiratory and 2.4% secondary bleeding). Those with OSAS present complications more frequently than those without7. Even though the surgery is considered succesful, up to 21.6% of those treated present persistence of the disease. Based on these results the American Academy of Pediatrics recommends considering polysomnography after surgery in those patients with high risk of persistence, such as obese children.
The continuous positive airway pressure (CPAP) device provides a continuous pressure through a mask, acting as a pneumatic ferule which keeps the upper airway permeable; with a lower possibility of obstruction. The adherence of pediatric patients to CPAP has been reported between 6 and 65% (which is one of the reasons it's not considered the first line treatment), with an use of 2.1 to 8.2 hours per night, and an AIH (apnea-hypopnea index) between 2 and 6 per hour. In adult patients, a reduction in trans and post-surgical risk has been found, and therefore its pre-surgical use is recommended. In children it is one of the strategies used to reduce surgical risk in OSAS, even though its use is not recommended in any of the main clinical guides of management of children with OSAS. Its use has been described in children with severe illness, and in other studies it was used in 18% of patients, but its real effect in the probable complications has not been prospectively studied.
In adult subjects, inflammation of upper airway has been reported, and it could play a role in the physiopathology of OSAS, with changes in the minimal sectional area and pharyngeal volume measured by MRI after use for 4 to 6 weeks of CPAP use. Albeit the physiopathology is not completely understood, it could be a consequence of the mechanical stress associated to obstruction of airflow, with the repeated trauma related with snore, jointly with the upper airway vibration and the suction from the collapse during the apneas the causes. CPAP eliminates respiratory events, which could cause a reduction in edema and inflammation.
Acoustic pharyngometry is a non-invasive method which uses sound reflection to quickly measure the sectional area of the upper airway in function of the distance from the oral aperture. It can be adapted to its use in children, obtaining highly reproducible results, even though it is limited to those who can follow instructions. In adults a difference was found between the minimum oropharyngeal area and the mean area after 1 week of CPAP use, but not between 1 week and 6 months of use, with a return to basal after a 1 week of nonuse. In our center change in volume and transversal oropharyngeal area have been found with acoustic pharyngometry since the second week of use of CPAP, of 5% at 2 weeks and 6% at 4 weeks. In children changes after surgery have been found, with increase in the minimal sectional area and oropharyngeal volume, even though its correlation with persistent OSAS has not been studied.
In order to study the changes in the upper airway after CPAP, acoustic pharyngometry will be performed before and after CPAP use, and 3 months after adenotonsillectomy to determinate the relation to persistent OSAS. The presurgical CPAP will be randomized in those children with diagnosis of mild to moderate OSAS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- All recruited children with diagnosis of mild to moderate OSAS will be randomized to suboptimal (CPAP at 4 cmH2O) or therapeutical (CPAP auto from 4 to 15 cmH2O) arms, from a predetermined list in two groups of 50, blocks of 10 patients. All patients with diagnosis of severe OSAS will receive therapeutic pressure, and are considered as part of a third arm not included in the sample size.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic | Experimental | Device: Continuous positive airway pressure (CPAP)Continuous positive airway pressure (CPAP) with automatic pressure from 4 to 15 cmH2O every night for one week, afterwards use of CPAP at the P90 of pressure determinated during automatic use for one week, via oronasal interface. |
| Suboptimal | Sham comparator | Device: Continuous positive airway pressure (CPAP)Continuous positive airway pressure (CPAP) every night for two weeks at fixed pressure of 4 cmH2O, via oronasal interface. |
| Severe OSAS | Other | Device: Continuous positive airway pressure (CPAP)Continuous positive airway pressure (CPAP) with automatic pressure from 4 to 15 cmH2O every night for one week, afterwards use of CPAP at the P90 of pressure determinated during automatic use for one week, via oronasal interface. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 4 and 14 years old. Both genders. Diagnosis of OSAS based on sleep study (respiratory polygraphy or polysomnography).
- Surgical treatment planned by the ORL department of the Institute of Respiratory Diseases of Mexico.
- Residents of the Metropolitan Area of Mexico City Parents and child accept to particpate in the study, singning informed consent and assent.
Key exclusion criteria (1 listed)
- Previous surgery in upper airway. Craneofacial malformation. Previous use of CPAP. Syndromatic patient.
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 |
|---|---|---|
| Continuous positive airway pressure (CPAP)CPAP dispositives will be used by the children in the study every night for two weeks. Devices AutoSet Spirit from ResMed. | Device | Severe OSAS, Suboptimal, Therapeutic |
Primary outcome
Oropharyngeal volume postCPAP.
Time frame: After two weeks of CPAP use.
Upper airway volume as measured by acoustic pharyngometry.
6 secondary outcomes
Oropharyngeal volume post-surgery
Time frame: Three months after adenotonsillectomy.
OSA-18.
Time frame: After two weeks of CPAP use.
OSA-18.
Time frame: Three months after adenotonsillectomy.
Pediatric Sleep Questionnaire.
Time frame: After two weeks of CPAP use.
Pediatric Sleep Questionnaire.
Time frame: Three months after adentonsillectomy.
Surgical complications.
Time frame: During and one month after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Background: PubMed 26541535Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5.
- Background: PubMed 26391937De Luca Canto G, Pacheco-Pereira C, Aydinoz S, Bhattacharjee R, Tan HL, Kheirandish-Gozal L, Flores-Mir C, Gozal D. Adenotonsillectomy Complications: A Meta-analysis. Pediatrics. 2015 Oct;136(4):702-18. doi: 10.1542/peds.2015-1283. Epub 2015 Sep 21.
- Background: PubMed 23118085Kang KT, Hsu WC. Adenotonsillectomy outcomes in treatment of obstructive sleep apnea in children: a multicenter retrospective study. Am J Respir Crit Care Med. 2012 Nov 1;186(9):927; author reply 927-8. doi: 10.1164/ajrccm.186.9.927. No abstract available.
- Background: PubMed 18835648Castorena-Maldonado A, Torre-Bouscoulet L, Meza-Vargas S, Vazquez-Garcia JC, Lopez-Escarcega E, Perez-Padilla R. Preoperative continuous positive airway pressure compliance in children with obstructive sleep apnea syndrome: assessed by a simplified approach. Int J Pediatr Otorhinolaryngol. 2008 Dec;72(12):1795-800. doi: 10.1016/j.ijporl.2008.08.016. Epub 2008 Oct 4.
- Background: PubMed 12045123Monahan KJ, Larkin EK, Rosen CL, Graham G, Redline S. Utility of noninvasive pharyngometry in epidemiologic studies of childhood sleep-disordered breathing. Am J Respir Crit Care Med. 2002 Jun 1;165(11):1499-503. doi: 10.1164/rccm.200111-061OC.
- Background: PubMed 18815823Corda L, Redolfi S, Montemurro LT, La Piana GE, Bertella E, Tantucci C. Short- and long-term effects of CPAP on upper airway anatomy and collapsibility in OSAH. Sleep Breath. 2009 May;13(2):187-93. doi: 10.1007/s11325-008-0219-1. Epub 2008 Sep 25.
- Individual participant dataSharing planned: No. Data from the study could be provided if solicited at the main author's e-mail adress.
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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.
José Rogelio Pérez-Padilla, MD study director
Instituto Nacional Enfermedades Respiratorias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure (CPAP) in people with Sleep Apnea, Obstructive and Child, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
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 3 inclusion and 1 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 12 Mar 2019. 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 Mexico. 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. Some participants in this study may receive a placebo. 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 Angélica M Portillo-Vásquez, MD (+525554871700 ext. 5242, ampvs1986@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal volume postCPAP. (time frame: After two weeks of CPAP use.). 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 NCT03169491, which also lists 6 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 12 Mar 2019.