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Completed

NCT Number: NCT02933112

Workflow Validation of an In-home Auto-titrating Mandibular Positioner

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Premier Sleep

Bellevue, Washington, 98005, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Minimum 18 years of age
  • Participant has been deemed suitable for oral appliance therapy
  • Prescription for oral appliance
  • Adequate range of motion
  • Adequate dentition
  • Ability to understand and provide informed consent
  • Ability and willingness to meet the required schedule

Exclusion criteria

  • Loose teeth or advanced periodontal disease
  • Full dentures or dental implants

Treatment and study plan

Auto-titrating mandibular positioner test

Device

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 outcomes

  1. Integration of the device into the existing workflow of a dental sleep medicine practice

    Time frame: 1 year

    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, prepare device for use, and ease of scheduling of study visits

  2. Convenience and feasibility of carrying out a multi-night AMP study in the home

    Time frame: 1 year

    Participants will complete a questionnaire following their AMP tests to collect data on ease of use of the device and opinion of the various device components.

  3. Feasibility of instructing the participant on the use of the AMP device at the practitioner's office

    Time frame: 1 year

    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 outcomes

  1. Time to treatment

    Time frame: 1 year

    Time to treatment 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: 1 year

    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: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Zephyr Sleep Technologies

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 14, 2016
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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