Sleep ApneaNCT05596825
Phenotypic Characteristics of Responders to Obstructive Sleep Apnea Treatment Using Mandibular Advancement Devices
An observational study of Sleep Apnea, run by University of Valencia.
Trial summary
Currently, mandibular advancement devices (MAD) are recommended by the American Academy of Sleep Medicine (AASM) as the first treatment a line in cases of mild and moderate OSAS in patients without severe cardiovascular comorbidity and in severe OSAS when treatment with CPAP fails or is rejected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Mandibular Advancement Device
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 8 Jul 2023to 29 Apr 2024
- Phase
- Observational
- 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
Study population: Patients from the Master's Degree in Prosthodontics and Occlusion at the University of Valencia will be selected. At the dental clinic of the Lluis Alcanyis Foundation. Located in Gascó Oliag Nº 1, Valencia.
Who may be able to join
- Patients older than 18 years
- Adult patients with obstructive sleep apnea diagnosed according to the third edition of the International Classification of Sleep Disorders.
- Apnea-hypopnea index (AHI) of at least 5/hour of sleep.
Who cannot join
- Patients with heart disease.
- Central sleep apnea.
- Patients who had degenerative pathologies of the temporomandibular joint.
- Patients who had moderate or advanced periodontal disease.
- Pregnant patients.
Trial locations and contacts
No sites are listed yet.
About this study
Currently, mandibular advancement devices (MAD) are recommended by the American Academy of Sleep Medicine (AASM) as the first treatment a line in cases of mild and moderate OSAS in patients without severe cardiovascular comorbidity and in severe OSAS when treatment with CPAP fails or is rejected. Although oral appliances (OD) have less impact on AHI reduction, both treatments have been shown to have a similar impact on clinical outcomes, including symptomatology and cardiovascular outcomes. In addition, MAD is a treatment that is better tolerated by patients, which results in greater compliance on their part, and therefore a similar efficacy in clinical practice.
Its mechanism of action consists of maintaining the patency of the upper airway, preventing collapse. They act by correcting the anatomical imbalance of patients with OSAS, specifically stabilizing and increasing the space of the velopharyngeal airways, reducing their collapsibility.
However, the effectiveness of the treatment of this pathology using MAD is limited by the inter-individual preference of the results of the treatment and the lack of information in the correct selection of the appropriate patients. In fact, oral appliances are an effective treatment for 60-70% of patients. Therefore, the precise selection of patients is essential to optimize the results of MAD treatment and thus avoid the necessary costs. This justifies the need to identify phenotypes likely to predict response to MAD treatment.
- Conditions
- Sleep Apnea
- Being tested
- Mandibular Advancement Device
- Keywords
- sleep apnea syndrome, mandibular advancement device
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Advancement DeviceDevice
To analyze the phenotypic characteristics of different subgroups of patients with obstructive sleep apnea syndrome who respond better (complete responders) or worse (partial responders or non-responders) to treatment with mandibular advancement devices.
Responders will be defined as a post-treatment AHI of less than 10/h and at least a 50 percent reduction in their AHI. Partial responders will be defined as a post-treatment AHI greater than 10/hour but at least a 50 percent reduction in AHI, and non-responders as less than a 50 percent reduction compared to baseline.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender
Male or Female
Measured: 1 day
Age
Age described as "years and months". The age of the patients at the beginning of the study
Measured: 1 day
Body mass index
Weight and height will be combined to report BMI in kg/m^2. The body mass index at the beginning of the study.
Measured: 1 day
Epworth Daytime Sleepiness Scale
The ESS is a self-administered questionnaire that evaluates sub- jective daytime sleepiness in quotidian situations. The score ranges from 0 to 24 and is usually elevated in sleep apnea patients, indicating a propensity to fall asleep. An ESS score above 10 is considered abnormal and a maximum score of 24 indicates severe somnolence.
Measured: 1 day
Anatomical characteristics
Craniofacial and airway features from cone beam computed tomography. (eg. maxillary length (mm), mandibular length (mm), anterior facial height (mm), posterior facial height (mm), distance between hyoid bone and mandibular plane (mm), distance between retrognation point and mandibular plane (mm), upper airway length (mm), superior airway space (mm) and inferior airway space (mm)).
Measured: 12 months
apnea - hypopnea index
number of apnea and hypopnea per hours of sleep before and after the device's placement.
Measured: 6 months
minimum oxygen saturation
It is the minimum oxyhemoglobin saturation during a sleep study. Expressed in %.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start8 Jul 2023 (estimated)
- Primary completion8 Dec 2023 (estimated)
- Study completion29 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596825
- Sponsor's protocol ID
- sacagon
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Camanes-Gonzalvo S, Montiel-Company JM, Garcia-Selva M, Plaza-Espin A, Perez-Carbonell T, Paredes-Gallardo V, Bellot-Arcis C, Marco-Pitarch R. Individualised Therapy for Obstructive Sleep Apnoea: Predictive Models and Anatomical Phenotyping of Mandibular Advancement Devices Responses. Orthod Craniofac Res. 2025 Jun;28(3):485-495. doi: 10.1111/ocr.12900. Epub 2025 Jan 24.
PubMed 39853867
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic Characteristics of Responders to Obstructive Sleep Apnea Treatment Using Mandibular Advancement Devices
- ClinicalTrials.gov ID
- NCT05596825
- Acronym / sponsor ID
- sacagon
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea syndrome, mandibular advancement device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 8 Jul 2023 (estimated)
- Primary completion
- 8 Dec 2023 (estimated)
- Study completion
- 29 Apr 2024 (estimated)
- First posted
- 27 Oct 2022 (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.
Currently, mandibular advancement devices (MAD) are recommended by the American Academy of Sleep Medicine (AASM) as the first treatment a line in cases of mild and moderate OSAS in patients without severe cardiovascular comorbidity and in severe OSAS when treatment with CPAP fails or is rejected. Although oral appliances (OD) have less impact on AHI reduction, both treatments have been shown to have a similar impact on clinical outcomes, including symptomatology and cardiovascular outcomes. In addition, MAD is a treatment that is better tolerated by patients, which results in greater compliance on their part, and therefore a similar efficacy in clinical practice.
Its mechanism of action consists of maintaining the patency of the upper airway, preventing collapse. They act by correcting the anatomical imbalance of patients with OSAS, specifically stabilizing and increasing the space of the velopharyngeal airways, reducing their collapsibility.
However, the effectiveness of the treatment of this pathology using MAD is limited by the inter-individual preference of the results of the treatment and the lack of information in the correct selection of the appropriate patients. In fact, oral appliances are an effective treatment for 60-70% of patients. Therefore, the precise selection of patients is essential to optimize the results of MAD treatment and thus avoid the necessary costs. This justifies the need to identify phenotypes likely to predict response to MAD treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the Master's Degree in Prosthodontics and Occlusion at the University of Valencia will be selected. At the dental clinic of the Lluis Alcanyis Foundation. Located in Gascó Oliag Nº 1, Valencia.
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Adult patients with obstructive sleep apnea diagnosed according to the third edition of the International Classification of Sleep Disorders.
- Apnea-hypopnea index (AHI) of at least 5/hour of sleep.
Key exclusion criteria (5 listed)
- Patients with heart disease.
- Central sleep apnea.
- Patients who had degenerative pathologies of the temporomandibular joint.
- Patients who had moderate or advanced periodontal disease.
- Pregnant patients.
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 |
|---|---|---|
| Mandibular Advancement DeviceTo analyze the phenotypic characteristics of different subgroups of patients with obstructive sleep apnea syndrome who respond better (complete responders) or worse (partial responders or non-responders) to treatment with mandibular advancement devices. Responders will be defined as a post-treatment AHI of less than 10/h and at least a 50 percent reduction in their AHI. Partial responders will be defined as a post-treatment AHI greater than 10/hour but at least a 50 percent reduction in AHI, and non-responders as less than a 50 percent reduction compared to baseline. | Device | – |
Primary outcome
Gender
Time frame: 1 day
Male or Female
Age
Time frame: 1 day
Age described as "years and months". The age of the patients at the beginning of the study
Body mass index
Time frame: 1 day
Weight and height will be combined to report BMI in kg/m^2. The body mass index at the beginning of the study.
Epworth Daytime Sleepiness Scale
Time frame: 1 day
The ESS is a self-administered questionnaire that evaluates sub- jective daytime sleepiness in quotidian situations. The score ranges from 0 to 24 and is usually elevated in sleep apnea patients, indicating a propensity to fall asleep. An ESS score above 10 is considered abnormal and a maximum score of 24 indicates severe somnolence.
Anatomical characteristics
Time frame: 12 months
Craniofacial and airway features from cone beam computed tomography. (eg. maxillary length (mm), mandibular length (mm), anterior facial height (mm), posterior facial height (mm), distance between hyoid bone and mandibular plane (mm), distance between retrognation point and mandibular plane (mm), upper airway length (mm), superior airway space (mm) and inferior airway space (mm)).
apnea - hypopnea index
Time frame: 6 months
number of apnea and hypopnea per hours of sleep before and after the device's placement.
minimum oxygen saturation
Time frame: 6 months
It is the minimum oxyhemoglobin saturation during a sleep study. Expressed in %.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Derived from this study: PubMed 39853867Camanes-Gonzalvo S, Montiel-Company JM, Garcia-Selva M, Plaza-Espin A, Perez-Carbonell T, Paredes-Gallardo V, Bellot-Arcis C, Marco-Pitarch R. Individualised Therapy for Obstructive Sleep Apnoea: Predictive Models and Anatomical Phenotyping of Mandibular Advancement Devices Responses. Orthod Craniofac Res. 2025 Jun;28(3):485-495. doi: 10.1111/ocr.12900. Epub 2025 Jan 24.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by University of Valencia.
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 5 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 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Sara Camañes Gonzalvo (660150240 ext. +34, saracamanes@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gender (time frame: 1 day). The study lists 7 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 NCT05596825, which also lists 1 linked publication.
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 15 May 2023.