Sleep Apnea, ObstructiveNCT05553860
Comparing Two Mandibular Positioning Techniques for Dental Sleep Appliances
A study testing Speech positioning technique in people with Sleep Apnea, Obstructive and Occlusal Splints, run by University of Alberta at 1 site in Canada.
Trial summary
This is a prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Occlusal Splints
- What is being tested?
- Speech positioning technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 5 Dec 2021to 3 Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient diagnosed with obstructive sleep apnea, and
- Prescription/order for a dental sleep appliance
- 18 years or older
- Treatment planned in accordance with AADSM treatment guidelines
Who cannot join
- There are no separate exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Cohort Prospective Single Blinded Patient Crossover Trial Comparing Anterior Protrusive and Sibilant Phoneme Mandibular Positioning Techniques for Dental Sleep Appliances
This is a prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.
Read the detailed description
Obstructive sleep apnea is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom-made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. Current methodology within dentistry is to position the mandible based on the person's maximum ability to position their mandible forward as the starting point and then slowly move the bottom jaw forward as necessary. Recent literature has shown that different mandibular positioning techniques may require less protrusion, less titrations, and potentially decreased side effects compared with the traditional protrusive techniques. One of the most promising techniques involves the use of speech to determine mandibular position. This technique would not require that a patient place their jaw outside of their normal functional range and could potentially decrease the face pain/jaw joint problems commonly associated with the use of oral sleep appliances for the treatment of obstructive sleep apnea. The use of speech as the determinant for where to position the mandible is important for muscular balance. Minimal research has been done in this area, with most studies being either retrospective or confounded by other variables. This will be the first prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.
- Conditions
- Sleep Apnea, Obstructive, Occlusal Splints
- Being tested
- Speech positioning technique
- 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.
Speech positioning techniqueOther
Speech positioning technique
| Study group | Role | What they receive |
|---|---|---|
| Anterior Protrusive | Active comparator | use of anterior protrusive positioning technique Receives: Other: Speech positioning technique |
| Speech Position | Experimental | use of speech positioning technique Receives: Other: Speech positioning technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index (AHI)
Measurement to determine whether both mandibular positioning techniques provide similar management of obstructive sleep apnea
Measured: 3 months
Secondary outcomes (1)
Overjet
Measurement to determine whether there is a significant difference in final treatment mandibular position between the positioning techniques.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start5 Dec 2021
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enoch Ng, DDS, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553860
- Sponsor's protocol ID
- Pro00097563
- Status last verified
- Mar 2026
- First submitted
- 21 Sep 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Cohort Prospective Single Blinded Patient Crossover Trial Comparing Anterior Protrusive and Sibilant Phoneme Mandibular Positioning Techniques for Dental Sleep Appliances
- ClinicalTrials.gov ID
- NCT05553860
- Acronym / sponsor ID
- Pro00097563
- Conditions
- Sleep Apnea, Obstructive, Occlusal Splints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 23 Sep 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.
This is a prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.
Detailed description
Obstructive sleep apnea is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom-made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. Current methodology within dentistry is to position the mandible based on the person's maximum ability to position their mandible forward as the starting point and then slowly move the bottom jaw forward as necessary. Recent literature has shown that different mandibular positioning techniques may require less protrusion, less titrations, and potentially decreased side effects compared with the traditional protrusive techniques. One of the most promising techniques involves the use of speech to determine mandibular position. This technique would not require that a patient place their jaw outside of their normal functional range and could potentially decrease the face pain/jaw joint problems commonly associated with the use of oral sleep appliances for the treatment of obstructive sleep apnea. The use of speech as the determinant for where to position the mandible is important for muscular balance. Minimal research has been done in this area, with most studies being either retrospective or confounded by other variables. This will be the first prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Protrusive | Active comparator | Other: Speech positioning techniqueuse of anterior protrusive positioning technique |
| Speech Position | Experimental | Other: Speech positioning techniqueuse of speech positioning technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient diagnosed with obstructive sleep apnea, and
- Prescription/order for a dental sleep appliance
- 18 years or older
- Treatment planned in accordance with AADSM treatment guidelines
Key exclusion criteria (1 listed)
- There are no separate exclusion criteria
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 |
|---|---|---|
| Speech positioning techniqueSpeech positioning technique | Other | Anterior Protrusive, Speech Position |
Primary outcome
Apnea-hypopnea index (AHI)
Time frame: 3 months
Measurement to determine whether both mandibular positioning techniques provide similar management of obstructive sleep apnea
1 secondary outcome
Overjet
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- 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.
Enoch Ng, DDS principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech positioning technique in people with Sleep Apnea, Obstructive and Occlusal Splints, run by University of Alberta at 1 site in Canada.
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 4 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: finished, as of the sponsor's last update on 18 Mar 2026. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Apnea-hypopnea index (AHI) (time frame: 3 months). 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 18 Mar 2026.