N/A
N=25
AutoSet for Her Clinical Trial Protocol
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01826513 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Apnoea Hypopnoea Index (AHI) — 0.96; 0.91 events/hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard AutoSet algorithm (Device); Modified AutoSet algorithm (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- ResMed
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnoea Hypopnoea Index (AHI) |
0.96; 0.91 | — |
| PRIMARY Oxygen Desaturation Index (ODI) |
1.92; 2.19 | — |
| SECONDARY Sleep Efficacy |
85.99; 84.14 | — |
| SECONDARY Wake After Sleep Onset Time |
47.52; 57.42 | — |
| SECONDARY Time Taken to Fall Asleep |
16.52; 16.25 | — |
| SECONDARY Number of Spontaneous Arousals |
85.55; 81.40 | — |
| SECONDARY Number of Hypopnoeas |
1.45; 2.00 | — |
| SECONDARY Number of Obstructive Apnoeas |
1.30; 0.80 | — |
| SECONDARY Number of Central Apnoeas |
3.55; 3.00 | — |
| SECONDARY Oxygen Saturation |
96.56; 96.31 | — |
| SECONDARY Percentage of Total Sleep Time Spent in Each Sleep Stage |
6.05; 6.20; 51.28; 49.44; 24.83; 24.60 | — |
| SECONDARY Number of Respiratory Event Related Arousals |
2.60; 1.30 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Pre-menopausal females aged ≥ 18 years
- Current positive airway pressure (PAP)(CPAP or APAP) therapy user with 'current' defined as on PAP therapy for at least 1 month prior to study entry
- Diagnostic PSG available
- Diagnosis of mild-moderate OSA (AHI ≤ 30)
- Participants willing and able to give written informed consent
Exclusion Criteria
- Participants currently using Bi-level PAP
- Participants currently using supplemental oxygen
- Participants who are pregnant
- Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)
- Participants who the researcher believes are unsuitable for inclusion because either:
- they do not comprehend English
- they are unable to provide written informed consent
- they are physically unable to comply with the protocol
Data sourced from ClinicalTrials.gov (NCT01826513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.