AutoSet for Her Clinical Trial Protocol

AutoSet for Her Clinical Trial Protocol

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.

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