---
title: The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
nct_id: NCT03725839
overall_status: COMPLETED
phase: NA
sponsor: Fisher and Paykel Healthcare
study_type: INTERVENTIONAL
primary_condition: Sleep Disordered Breathing
countries: New Zealand
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03725839.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03725839"
ct_last_update_post_date: 2020-02-28
last_seen_at: "2026-05-12T06:27:40.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

**NCT ID:** [NCT03725839](https://clinicaltrials.gov/study/NCT03725839)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 33
- **Lead Sponsor:** Fisher and Paykel Healthcare
- **Conditions:** Sleep Disordered Breathing, Obstructive Sleep Apnea
- **Start Date:** 2018-11-05
- **Completion Date:** 2019-11-30
- **CT.gov Last Update:** 2020-02-28

## Brief Summary

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.

## Detailed Description

A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.

## Eligibility

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

```
Inclusion Criteria:

* Adult (18+ years of age)
* Able to give written consent
* AHI ≥ 5 on diagnostic night
* Either prescribed APAP, CPAP or Bi-level PAP for OSA

Exclusion Criteria:

* Inability to give written consent
* Anatomical or physiological conditions making PAP therapy inappropriate
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or may think they are pregnant.
```

## Arms

- **Arm** (EXPERIMENTAL) — F\&P Interface will be used by OSA participants in-home for 2 weeks.

## Interventions

- **F&P Interface** (DEVICE) — F\&P Interface to be used for OSA therapy

## Primary Outcomes

- **Trial Mask usability** _(time frame: 14 ± 4 days in home)_ — Questionnaire on ease-of-use (very easy to very difficult) Subjective
- **Trial mask Performance** _(time frame: 14 ± 4 days in home)_ — Questionnaire on performance (very good to very poor)- Subjective

## Secondary Outcomes

- **Trial mask Reliability** _(time frame: 5 months and 2 weeks in home)_
- **Trial mask performance measured in L/min** _(time frame: 14 ± 4 days in home)_

## Locations (3)

- Hawkes Bay Fallen Soldiers' Memorial Hospital, Hastings, Hawkes Bay, New Zealand
- Fisher & Paykel Healthcare, Auckland, New Zealand
- Well Sleep, Wellington, New Zealand

## 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.hawkes bay fallen soldiers' memorial hospital|hastings|hawkes bay|new zealand` — added _(2026-05-12)_
- `locations.fisher & paykel healthcare|auckland||new zealand` — added _(2026-05-12)_
- `locations.well sleep|wellington||new zealand` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03725839.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03725839*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*