Obstructive Sleep ApneaNCT01069068
Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry
An observational study of Obstructive Sleep Apnea, run by Doctor's Directive Strategies Inc. at 1 site in Canada.
Trial summary
Mandibular advancements during tidal breathing, achieved through a stepped mouthpiece design, affect the size of the upper airways in subjects with and without Obstructive Sleep Apnea. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Apr 2010
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be performed as an open investigation including 60 subjects. The 60 subjects will be stratified such that 30 subjects should have been diagnosed with OSA, and 30 subjects should not have been diagnosed with OSA.
Who may be able to join
- Subjects must provide written informed consent to participate in the study.
- Adult male or female subjects over 18 years of age who have or have not been diagnosed with OSA.
- Subjects claiming no history of OSA should take the Epworth questionnaire and obtain a result less than 10.
- Subjects must satisfy the study investigator about their fitness to participate in the study.
- Subjects must be available to complete the study.
Who cannot join
- Subjects not compliant with the instructions for use of the stepped mouthpiece and the study procedures.
- Subjects who have participated in a clinical trial in the previous month.
Trial locations and contacts
1 site in 1 country.
About this study
Mandibular advancements during tidal breathing, achieved through a stepped mouthpiece design, affect the size of the upper airways in subjects with and without Obstructive Sleep Apnea.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- To evaluate the effect of advancing Jaw on airway dimension
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the impact of different horizontal mandibular advancements, achieved through a stepped mouthpiece design, on the size of the upper airways in subjects with and without Obstructive Sleep Apnea (OSA).
Measured: one 60 minute session
Secondary outcomes (4)
Assessment of the habitual mandibular position in (edge-to-edge, millimetres) relation to the front upper teeth
Measured: one 60 minute session
Measurement of the upper airways through acoustic pharyngometry during slow and deep breathing while the subject uses a stepped mouthpiece. The acoustic pharyngometry measurement will be performed at mid inhalation
Measured: one 60 minute session
Assessment of the most comfortable position when using the stepped mouthpiece during both "tidal" and "slow and deep breathing". The scoring of the "comfortable position" will be performed through a Likert-style questionnaire
Measured: one 60 minute session
The most "comfortable position" established as outlined above will be evaluated for comfort while holding that position for 3 minutes. After the 3 minutes, the subject's level of comfort will be re-evaluated through a Likert-style questionnaire
Measured: one 60 minute session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Doctor's Directive Strategies Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr John Viviano, Doctor's Directive Strategies Inc.
- Investigators
- John S Viviano, DDS, Principal investigator, Dr John Viviano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069068
- Sponsor's protocol ID
- RDD-2009-001
- Status last verified
- Dec 2011
- First submitted
- 16 Feb 2010
- Last updated
- 9 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry
- ClinicalTrials.gov ID
- NCT01069068
- Acronym / sponsor ID
- RDD-2009-001
- Conditions
- Obstructive Sleep Apnea
- Keywords
- To evaluate the effect of advancing Jaw on airway dimension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Doctor's Directive Strategies Inc.University, hospital or other
- Study start
- Feb 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Feb 2010 (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.
Mandibular advancements during tidal breathing, achieved through a stepped mouthpiece design, affect the size of the upper airways in subjects with and without Obstructive Sleep Apnea.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be performed as an open investigation including 60 subjects. The 60 subjects will be stratified such that 30 subjects should have been diagnosed with OSA, and 30 subjects should not have been diagnosed with OSA.
Key inclusion criteria (5 listed)
- Subjects must provide written informed consent to participate in the study.
- Adult male or female subjects over 18 years of age who have or have not been diagnosed with OSA.
- Subjects claiming no history of OSA should take the Epworth questionnaire and obtain a result less than 10.
- Subjects must satisfy the study investigator about their fitness to participate in the study.
- Subjects must be available to complete the study.
Key exclusion criteria (2 listed)
- Subjects not compliant with the instructions for use of the stepped mouthpiece and the study procedures.
- Subjects who have participated in a clinical trial in the previous month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To measure the impact of different horizontal mandibular advancements, achieved through a stepped mouthpiece design, on the size of the upper airways in subjects with and without Obstructive Sleep Apnea (OSA).
Time frame: one 60 minute session
4 secondary outcomes
Assessment of the habitual mandibular position in (edge-to-edge, millimetres) relation to the front upper teeth
Time frame: one 60 minute session
Measurement of the upper airways through acoustic pharyngometry during slow and deep breathing while the subject uses a stepped mouthpiece. The acoustic pharyngometry measurement will be performed at mid inhalation
Time frame: one 60 minute session
Assessment of the most comfortable position when using the stepped mouthpiece during both "tidal" and "slow and deep breathing". The scoring of the "comfortable position" will be performed through a Likert-style questionnaire
Time frame: one 60 minute session
The most "comfortable position" established as outlined above will be evaluated for comfort while holding that position for 3 minutes. After the 3 minutes, the subject's level of comfort will be re-evaluated through a Likert-style questionnaire
Time frame: one 60 minute session
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 9 Dec 2011.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
John S Viviano, DDS principal investigator
Dr John Viviano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Doctor's Directive Strategies Inc. 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 5 inclusion and 2 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 9 Dec 2011. 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?
To measure the impact of different horizontal mandibular advancements, achieved through a stepped mouthpiece design, on the size of the upper airways in subjects with and without Obstructive Sleep Apnea (OSA). (time frame: one 60 minute session). 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 9 Dec 2011.