A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test
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|ClinicalTrials.gov Identifier: NCT03049982|
Recruitment Status : Recruiting
First Posted : February 10, 2017
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Auto-titrating mandibular positioner test||Not Applicable|
One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner.
The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test|
|Actual Study Start Date :||February 7, 2017|
|Estimated Primary Completion Date :||August 1, 2018|
|Estimated Study Completion Date :||August 1, 2018|
AMP test group
All individuals will undergo a test using the auto-titrating mandibular positioner.
Device: Auto-titrating mandibular positioner test
Participants will undergo a theragnostic test using the auto-titrating mandibular positioner to determine if they are eligible candidates to use oral appliance therapy for their obstructive sleep apnea. The device works by moving the lower jaw forward in response to respiratory events while the participant sleeps. All participants will undergo the same test.
- Integration of the device into the existing workflow of a dental sleep medicine practice [ Time Frame: 6 months ]Data for this outcome are largely directed at the study staff, not study participants. Data collected for this outcome include: time required to evaluate eligibility for device use, time required to prepare device for use.
- Convenience/feasibility of carrying out a multi-night AMP study in the home [ Time Frame: 6 months ]Participants will complete a questionnaire following their AMP tests to collect data on participants' opinion of the device (includes opinion of various device components, ease of use of the device).
- Feasibility of instructing the participant on the use of the AMP device at the practitioner's office [ Time Frame: 6 months ]Data for this outcome are directed at study staff, not study participants. Data collected will include feedback on ease of training participants on device use. Participants will be asked if they felt they received adequate training from the study staff via a questionnaire.
- Time to therapy [ Time Frame: 6 months ]Time to therapy will be evaluated by tracking the time from the first consultation at the dentist's office to the setting of the temporary appliance (for individuals whose tests indicate they are predicted candidates for oral appliance therapy).
- Number of study visits [ Time Frame: 6 months ]The number of study visits will be recorded. This data will be collected from study records and does not require input from the participant.
- Length of study visits [ Time Frame: 6 months ]The length of each visit (minutes) will be recorded. This data will be collected from study records and does not require input from the participant.
- Ease of scheduling study visits [ Time Frame: 6 months ]The ease of scheduling will be discussed with the study staff to collect data on ease of integration of the device into the practice.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049982
|Contact: Michael Simmons, DMD, MSc||818-300-0070|
|Contact: Pamela Simmons||818-300-0070|
|United States, California|
|Encino Center for Sleep and TMJ Disorders||Recruiting|
|Encino, California, United States, 91436|
|Contact: Michael Simmons, DMD, MSc 818-300-0070|
|Contact: Pamela Simmons 818-300-0070|
|Principal Investigator: Michael Simmons, DMD, MSc|