A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test

Zephyr Sleep Technologies

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Auto-titrating mandibular positioner test

Study type: Interventional

Funder types: Industry

Identifiers

NCT03049982

ZCP2016_03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

AMP test group

Other group

Description:

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

Treatment:

Device: Auto-titrating mandibular positioner test