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

NCT02933112 | Completed DMC

• 1 other identifier: ZCP2015_02
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Oral appliance therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Time to treatment

  1 year

• Number of study visits

  1 year

• Length of study visits

  1 year

Study Arms (1)

AMP test group

OTHER

All individuals will undergo a test using the auto-titrating mandibular positioner.

Device: Auto-titrating mandibular positioner test

Interventions

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.

AMP test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zephyr Sleep Technologies: lead

Study Sites (1)

Premier Sleep

Bellevue, Washington, 98005, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephen Carstensen, DDS

  Premier Sleep

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 14, 2016
• Study Start: October 1, 2016
• Primary Completion: September 4, 2018
• Study Completion: October 11, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)