---
title: A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test
nct_id: NCT03049982
overall_status: COMPLETED
phase: NA
sponsor: Zephyr Sleep Technologies
study_type: INTERVENTIONAL
primary_condition: Obstructive Sleep Apnea
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03049982.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03049982"
ct_last_update_post_date: 2019-02-07
last_seen_at: "2026-05-12T06:56:39.013Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test

**NCT ID:** [NCT03049982](https://clinicaltrials.gov/study/NCT03049982)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 28
- **Lead Sponsor:** Zephyr Sleep Technologies
- **Conditions:** Obstructive Sleep Apnea
- **Start Date:** 2017-02-07
- **Completion Date:** 2018-10-17
- **CT.gov Last Update:** 2019-02-07

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **AMP test group** (OTHER) — All individuals will undergo a test using the auto-titrating mandibular positioner.

## 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.

## Primary Outcomes

- **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.
- **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).
- **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 Outcomes

- **Time to therapy** _(time frame: 6 months)_
- **Number of study visits** _(time frame: 6 months)_
- **Length of study visits** _(time frame: 6 months)_
- **Ease of scheduling study visits** _(time frame: 6 months)_

## Locations (1)

- Encino Center for Sleep and TMJ Disorders, Encino, California, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.encino center for sleep and tmj disorders|encino|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03049982.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03049982*  
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