Obstructive Sleep ApneaNCT02056327
Evaluating Instrumentation for Dental Devices Used in Treating Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Oral appliances are an accepted means to treat obstructive sleep apnea. We propose to develop monitoring sensors that could be inserted into commercially available oral appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- A novel monitoring suite of sensors will be inserted into the standard oral device.
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Mar 2014
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults diagnosed with obstructive sleep apnea who are currently being treated with an oral appliance or who wish to transition to an oral appliance
Who may be able to join
- Ages 21-65
- Diagnosed with obstructive sleep apnea actively treated with an oral appliance or interested in transitioning to an oral appliance
- Ability to give informed consent
Who cannot join
- Significant physical illness that might impair the ability to participate
- Pregnant women will be excluded
- Subjects presently taking medication such as beta blockers or alpha agonists know to alter the autonomic nervous system
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Phase One Study Evaluating Instrumentation for Dental Devices Used in Treating Sleep Apnea
Oral appliances are an accepted means to treat obstructive sleep apnea. We propose to develop monitoring sensors that could be inserted into commercially available oral appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea.
Read the detailed description
Oral appliances are an accepted means to treat obstructive sleep apnea. In order to determine if they are effective, a polysomnogram needs to be conducted with the oral appliance in place. We propose to develop monitoring sensors that could be inserted into commercially available oral appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea. We propose to look at heart rate variability as a marker for ongoing sleep apnea. We will use temperature as means of detecting how long the device is in the mouth as a means of assessing adherence.
The objective of the Phase I project is to validate this hypothesis by answering five questions:
- What is the optimal sensor suite? We will determine the optimal suite of sensors that provides adequate sensitivity and specificity to determine OA usage and effectiveness without compromising patient comfort.
- Can we develop designs that are compatible with the most popular OAs? We will design and develop prototype versions of the OAMS that are compatible with three of the most popular commercially available OAMS products (potential candidates include EMA, TAP, SomnoDent, Herbst, Suad).
- Do experienced dental care providers who specialize in OAs approve of the designs? We will collaborate with dental care clinicians to iteratively refine the OAMS design for maximum performance and patient comfort.
- Does the OAMS provide data that are consistent with PSG instrumentation? We will collaborate with the Dartmouth-Hitchcock Medical Center (DHMC) Sleep Disorders Laboratory to assess OAMS sensor accuracy for approximately five healthy volunteers by comparing OSA-related OAMS data with data from standard PSG instrumentation.
- Can we formulate a cogent Human Subject Testing plan for Phase II? We will develop a detailed HST study plan to be conducted in Phase II to demonstrate fully integrated and functional OAMS in a broad range of OSA patients who are candidates for an OA.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- A novel monitoring suite of sensors will be inserted into the standard oral device.
- Keywords
- 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.
A novel monitoring suite of sensors will be inserted into the standard oral device.Device
| Study group | Role | What they receive |
|---|---|---|
| Oral appliance with monitoring suite | Subjects will sleep with a standard oral appliance with the newly developed monitoring suite embedded within it for 1-2 nights while being monitored with standard in lab polysomnography or home sleep testing. Receives: Device: A novel monitoring suite of sensors will be inserted into the standard oral device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography
We will perform standard in-lab polysomnography or home sleep testing to assess the ability of the sensors embedded in the oral appliance to detect ongoing obstructive sleep apnea
Measured: One to two nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
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.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Creare, Inc.
- Responsible party
- Principal investigator, Glen P. Greenough, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056327
- Sponsor's protocol ID
- HHSN268201300056C
- Status last verified
- Mar 2014
- First submitted
- 4 Feb 2014
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase One Study Evaluating Instrumentation for Dental Devices Used in Treating Sleep Apnea
- ClinicalTrials.gov ID
- NCT02056327
- Acronym / sponsor ID
- HHSN268201300056C
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Oral Appliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Creare, Inc.
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Feb 2014 (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.
Oral appliances are an accepted means to treat obstructive sleep apnea. We propose to develop monitoring sensors that could be inserted into commercially available oral appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea.
Detailed description
Oral appliances are an accepted means to treat obstructive sleep apnea. In order to determine if they are effective, a polysomnogram needs to be conducted with the oral appliance in place. We propose to develop monitoring sensors that could be inserted into commercially available oral appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea. We propose to look at heart rate variability as a marker for ongoing sleep apnea. We will use temperature as means of detecting how long the device is in the mouth as a means of assessing adherence.
The objective of the Phase I project is to validate this hypothesis by answering five questions:
- What is the optimal sensor suite? We will determine the optimal suite of sensors that provides adequate sensitivity and specificity to determine OA usage and effectiveness without compromising patient comfort.
- Can we develop designs that are compatible with the most popular OAs? We will design and develop prototype versions of the OAMS that are compatible with three of the most popular commercially available OAMS products (potential candidates include EMA, TAP, SomnoDent, Herbst, Suad).
- Do experienced dental care providers who specialize in OAs approve of the designs? We will collaborate with dental care clinicians to iteratively refine the OAMS design for maximum performance and patient comfort.
- Does the OAMS provide data that are consistent with PSG instrumentation? We will collaborate with the Dartmouth-Hitchcock Medical Center (DHMC) Sleep Disorders Laboratory to assess OAMS sensor accuracy for approximately five healthy volunteers by comparing OSA-related OAMS data with data from standard PSG instrumentation.
- Can we formulate a cogent Human Subject Testing plan for Phase II? We will develop a detailed HST study plan to be conducted in Phase II to demonstrate fully integrated and functional OAMS in a broad range of OSA patients who are candidates for an OA.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral appliance with monitoring suite | – | Device: A novel monitoring suite of sensors will be inserted into the standard oral device.Subjects will sleep with a standard oral appliance with the newly developed monitoring suite embedded within it for 1-2 nights while being monitored with standard in lab polysomnography or home sleep testing. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with obstructive sleep apnea who are currently being treated with an oral appliance or who wish to transition to an oral appliance
Key inclusion criteria (3 listed)
- Ages 21-65
- Diagnosed with obstructive sleep apnea actively treated with an oral appliance or interested in transitioning to an oral appliance
- Ability to give informed consent
Key exclusion criteria (3 listed)
- Significant physical illness that might impair the ability to participate
- Pregnant women will be excluded
- Subjects presently taking medication such as beta blockers or alpha agonists know to alter the autonomic nervous system
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 |
|---|---|---|
| A novel monitoring suite of sensors will be inserted into the standard oral device. | Device | Oral appliance with monitoring suite |
Primary outcome
Polysomnography
Time frame: One to two nights
We will perform standard in-lab polysomnography or home sleep testing to assess the ability of the sensors embedded in the oral appliance to detect ongoing obstructive sleep apnea
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 27 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dartmouth-Hitchcock Medical Center 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 3 inclusion and 3 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 27 Mar 2014. 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?
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?
Polysomnography (time frame: One to two nights). 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 27 Mar 2014.