Obstructive Sleep ApneaNCT05139303
Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.
A study testing Orthoapnea NOA® in people with Obstructive Sleep Apnea, run by Isabel Moreno Hay at 1 site in United States.
Trial summary
The objective of this study is to assess the efficacy of the Orthoapnea NOA® mandibular advancement device and describe the percentage of advancement (%) needed to reach efficacy, and to retrospectively compare with other MAD designs in the management of obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Orthoapnea NOA®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 2 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: >18 and <80 years old.
- No history of previous use of a MAD.
- Diagnosis of OSA by a sleep physician based on a PSG or HSAT (done >12 months before evaluation date or > 12 months with >10% variation of BMI).
- Upon clinical examination: >8 teeth per arch; range of anteroposterior mandibular mobility >5 mm.
- Informed consent to participate in the study.
Who cannot join
- Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder).
- History of previous allergic reaction to the appliance material (Polyamide 12).
- Patients using combination therapy for the management of OSA (i.e. PAP therapy or positional therapy).
- Upon clinical examination: periodontal disease (>4 mm on periodontal probing, with bleeding on probing, visual signs of periodontal inflammation); tooth horizontal mobility >1 mm, vertical mobility, and unfavorable crown to root ratio; open cavities, loose or fractured restorations, or patient undergoing restorative dental treatments.
- Exaggerated gag reflex.
- Lack of coordination or dexterity.
- Inadequate English comprehension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea. Clinical Trial and Retrospective Comparison Study.
The objective of this study is to assess the efficacy of the Orthoapnea NOA® mandibular advancement device and describe the percentage of advancement (%) needed to reach efficacy, and to retrospectively compare with other MAD designs in the management of obstructive sleep apnea. Additionally, to describe patient compliance and adherence to the therapy with the Orthoapnea NOA® device, and to assess the incidence and prevalence of signs, symptoms, and diagnosis of temporomandibular disorders (TMD) associated to the use of the Orthoapnea NOA® mandibular advancement device.
Read the detailed description
Participants were recruited consecutively from patients referred by a board certified sleep physician to the Orofacial Pain Clinic (University of Kentucky, Lexington, Kentucky, USA) for the management of OSA with a mandibular advancement device. An NOA® appliance (Orthoapnea S.L., Malaga, Spain) was custom made for each participant. Digital impressions (scanner 3Shape TRIOS® 3, Copenhagen, Denmark), protrusive records at 50% from maximum protrusion (using a 5 mm fork and George GaugeTM, Great Lakes Dental Technologies, Tonawanda, NY, USA), and clinical pictures were obtained following the protocol recommended by the manufacturer. Maximum mouth opening was measured by adding the interincisal distance to the overbite (in millimeters, using TheraBite® Range of Motion ruler, Great Lakes Dental Technologies, Tonawanda, NY, USA). The MAD was fabricated at an initial protrusion of 50%, with subsequent progressive mandibular components of additional 10% of protrusion up to 100% of the maximum protrusive range. Lastly, a full coverage morning deprogrammer (TAP® AM Aligner, World Class Technology Corp., McMinniville, OR, USA) was fabricated for all the participants to be used for 10 minutes upon removal of the MAD. Follow up visits were scheduled every two weeks and measures of compliance, sleep parameters, pain, headaches, TMD and side effects were monitored.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Orthoapnea NOA®
- Keywords
- OSA, Obstructive sleep apnea, mandibular advancement device, oral appliance
- 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.
Orthoapnea NOA®Device
The efficacy of the appliance for the management of OSA will be stablished based on two criteria. Criterion I: > 50% reduction of AHI/RDI. Criterion II: AHI/RDI < 5 events/hour or <15 events/hour with a significative reduction of OSA associates symptoms as defined before. Therapeutic failure will be established when at 100% of advancement of the device, there is less than 50% of reduction of the AHI/RDI with a residual AHI/RDI >5 events/hour with OSA associates symptoms.
| Study group | Role | What they receive |
|---|---|---|
| MAD therapy | Experimental | An NOA® appliance (Orthoapnea S.L., Malaga, Spain) was custom made for each participant at 50% from maximum protrusion. Receives: Device: Orthoapnea NOA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD)
Assessment of efficacy of the device: After delivery, the MAD will be advanced 10% every 2 weeks until maximum therapeutic benefit. Sleep parameters (apnea hypopnea index (AHI) and minimum oxygen saturation) will be extracted from the initial polysomnography (PSG), and from a final confirmatory home sleep apnea test. The efficacy will be stablished based on: Criterion I: > 50% reduction of AHI; Criterion II: AHI < 5 events/hour or <15 events/hour with a significant reduction of obstructive sleep apnea (OSA) associated symptoms.
Measured: 16 weeks.
% of Advancement of the Jaw Needed to Achieve Efficacy With the Use of the Mandibular Advancement Device (MAD) Based on the Success Criterion I and II
Criterion I: > 50% reduction of AHI/RDI. Criterion II: AHI/RDI < 5 events/hour or <15 events/hour with a significative reduction of OSA associates symptoms as defined before. Therapeutic failure will be established when at 100% of advancement of the device, there is less than 50% of reduction of the AHI/RDI with a residual AHI/RDI >5 events/hour with OSA associates symptoms.
Measured: 16 weeks
Secondary outcomes (1)
Number of Participants Compliant to the Mandibular Advancement Device (MAD)
The self-reported use of mandibular advancement device (MAD) was assessed at each follow-up via questionnaire on a five-point checklist (number hours per night and nights per week). Compliance was defined as wearing the appliance for ≥4 hours per night during at least 70% of the nights.
Measured: 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start15 Nov 2021
- Primary completion2 Aug 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabel Moreno Hay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Isabel Moreno Hay, University of Kentucky
- Investigators
- Isabel Moreno Hay, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139303
- Sponsor's protocol ID
- 71295
- Status last verified
- Oct 2024
- First submitted
- 4 Nov 2021
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea. Clinical Trial and Retrospective Comparison Study.
- ClinicalTrials.gov ID
- NCT05139303
- Acronym / sponsor ID
- 71295
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, Obstructive sleep apnea, mandibular advancement device, oral appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Isabel Moreno HayUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the efficacy of the Orthoapnea NOA® mandibular advancement device and describe the percentage of advancement (%) needed to reach efficacy, and to retrospectively compare with other MAD designs in the management of obstructive sleep apnea. Additionally, to describe patient compliance and adherence to the therapy with the Orthoapnea NOA® device, and to assess the incidence and prevalence of signs, symptoms, and diagnosis of temporomandibular disorders (TMD) associated to the use of the Orthoapnea NOA® mandibular advancement device.
Detailed description
Participants were recruited consecutively from patients referred by a board certified sleep physician to the Orofacial Pain Clinic (University of Kentucky, Lexington, Kentucky, USA) for the management of OSA with a mandibular advancement device. An NOA® appliance (Orthoapnea S.L., Malaga, Spain) was custom made for each participant. Digital impressions (scanner 3Shape TRIOS® 3, Copenhagen, Denmark), protrusive records at 50% from maximum protrusion (using a 5 mm fork and George GaugeTM, Great Lakes Dental Technologies, Tonawanda, NY, USA), and clinical pictures were obtained following the protocol recommended by the manufacturer. Maximum mouth opening was measured by adding the interincisal distance to the overbite (in millimeters, using TheraBite® Range of Motion ruler, Great Lakes Dental Technologies, Tonawanda, NY, USA). The MAD was fabricated at an initial protrusion of 50%, with subsequent progressive mandibular components of additional 10% of protrusion up to 100% of the maximum protrusive range. Lastly, a full coverage morning deprogrammer (TAP® AM Aligner, World Class Technology Corp., McMinniville, OR, USA) was fabricated for all the participants to be used for 10 minutes upon removal of the MAD. Follow up visits were scheduled every two weeks and measures of compliance, sleep parameters, pain, headaches, TMD and side effects were monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAD therapy | Experimental | Device: Orthoapnea NOA®An NOA® appliance (Orthoapnea S.L., Malaga, Spain) was custom made for each participant at 50% from maximum protrusion. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: >18 and <80 years old.
- No history of previous use of a MAD.
- Diagnosis of OSA by a sleep physician based on a PSG or HSAT (done >12 months before evaluation date or > 12 months with >10% variation of BMI).
- Upon clinical examination: >8 teeth per arch; range of anteroposterior mandibular mobility >5 mm.
- Informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder).
- History of previous allergic reaction to the appliance material (Polyamide 12).
- Patients using combination therapy for the management of OSA (i.e. PAP therapy or positional therapy).
- Upon clinical examination: periodontal disease (>4 mm on periodontal probing, with bleeding on probing, visual signs of periodontal inflammation); tooth horizontal mobility >1 mm, vertical mobility, and unfavorable crown to root ratio; open cavities, loose or fractured restorations, or patient undergoing restorative dental treatments.
- Exaggerated gag reflex.
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 |
|---|---|---|
| Orthoapnea NOA®The efficacy of the appliance for the management of OSA will be stablished based on two criteria. Criterion I: > 50% reduction of AHI/RDI. Criterion II: AHI/RDI < 5 events/hour or <15 events/hour with a significative reduction of OSA associates symptoms as defined before. Therapeutic failure will be established when at 100% of advancement of the device, there is less than 50% of reduction of the AHI/RDI with a residual AHI/RDI >5 events/hour with OSA associates symptoms. | Device | MAD therapy |
Primary outcome
To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD)
Time frame: 16 weeks.
Assessment of efficacy of the device: After delivery, the MAD will be advanced 10% every 2 weeks until maximum therapeutic benefit. Sleep parameters (apnea hypopnea index (AHI) and minimum oxygen saturation) will be extracted from the initial polysomnography (PSG), and from a final confirmatory home sleep apnea test. The efficacy will be stablished based on: Criterion I: > 50% reduction of AHI; Criterion II: AHI < 5 events/hour or <15 events/hour with a significant reduction of obstructive sleep apnea (OSA) associated symptoms.
% of Advancement of the Jaw Needed to Achieve Efficacy With the Use of the Mandibular Advancement Device (MAD) Based on the Success Criterion I and II
Time frame: 16 weeks
Criterion I: > 50% reduction of AHI/RDI. Criterion II: AHI/RDI < 5 events/hour or <15 events/hour with a significative reduction of OSA associates symptoms as defined before. Therapeutic failure will be established when at 100% of advancement of the device, there is less than 50% of reduction of the AHI/RDI with a residual AHI/RDI >5 events/hour with OSA associates symptoms.
1 secondary outcome
Number of Participants Compliant to the Mandibular Advancement Device (MAD)
Time frame: 16 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Isabel Moreno Hay principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthoapnea NOA® in people with Obstructive Sleep Apnea, run by Isabel Moreno Hay at 1 site in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 12 Nov 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) (time frame: 16 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.