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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
Sponsor:
Information provided by (Responsible Party):
Zephyr Sleep Technologies

Brief Summary:
The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Auto-titrating mandibular positioner test Not Applicable

Detailed Description:

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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Minimum 18 years of age
  2. Participant has been deemed suitable for oral appliance therapy
  3. Prescription for oral appliance
  4. Adequate range of motion
  5. Adequate dentition
  6. Ability to understand and provide informed consent
  7. Ability and willingness to meet the required schedule

Exclusion Criteria:

  1. Loose teeth or advanced periodontal disease
  2. Full dentures

Information from the National Library of Medicine

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


Contacts
Contact: Michael Simmons, DMD, MSc 818-300-0070
Contact: Pamela Simmons 818-300-0070

Locations
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         
Sponsors and Collaborators
Zephyr Sleep Technologies

Responsible Party: Zephyr Sleep Technologies
ClinicalTrials.gov Identifier: NCT03049982     History of Changes
Other Study ID Numbers: ZCP2016_03
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zephyr Sleep Technologies:
Oral appliance therapy

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias