Trials / Completed
CompletedNCT01826513
AutoSet for Her Clinical Trial Protocol
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- ResMed · Industry
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients. Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm. User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Standard AutoSet algorithm | An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender. |
| DEVICE | Modified AutoSet algorithm | An AutoSet device with an algorithm developed for sleep breathing parameters specific to females. |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2013-04-08
- Last updated
- 2017-03-27
- Results posted
- 2017-03-27
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT01826513. Inclusion in this directory is not an endorsement.