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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Auto-titrating mandibular positioner test

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
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bellevue, Washington, United States, 98005
      • Premier Sleep

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 or dental implants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integration of the device into the existing workflow of a dental sleep medicine practice	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	1 year
Convenience and feasibility of carrying out a multi-night AMP study in the home	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.	1 year
Feasibility of instructing the participant on the use of the AMP device at the practitioner's office	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment	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).	1 year
Number of study visits	The number of study visits will be recorded. This data will be collected from study records and does not require input from the participant.	1 year
Length of study visits	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.	1 year

Collaborators and Investigators

• Sponsor: Zephyr Sleep Technologies
• Investigators: Principal Investigator: Stephen Carstensen, DDS, Premier Sleep

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): September 4, 2018
• Study Completion (Actual): October 11, 2018

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Oral appliance therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: ZCP2015_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO