Clinical trial NCT01826513: AutoSet for Her Clinical Trial Protocol
Official title: AutoSet for Her Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Efficacy
Subjective feedback
Preference
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: The University of Western Australia
First posted: 2013-04-08
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Apnoea Hypopnoea Index (AHI)
timeFrame: 1 day
measure: Oxygen Desaturation Index (ODI)
timeFrame: 1 day
Secondary outcomes:
measure: Sleep Efficacy
timeFrame: 1 day
measure: Wake After Sleep Onset Time
timeFrame: 1 day
measure: Time Taken to Fall Asleep
timeFrame: 1 day
measure: Number of Spontaneous Arousals
timeFrame: 1 day
measure: Number of Hypopnoeas
timeFrame: 1 day
measure: Number of Obstructive Apnoeas
timeFrame: 1 day
measure: Number of Central Apnoeas
timeFrame: 1 day
measure: Oxygen Saturation
timeFrame: 1 day
measure: Percentage of Total Sleep Time Spent in Each Sleep Stage
timeFrame: 1 day
measure: Number of Respiratory Event Related Arousals
timeFrame: 1 day
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: West Australian Sleep Disorders Research Institute
state: Western Australia
Study officials:
affiliation: Centre for Sleep Science, University of Western Australia
name: Peter Eastwood, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: West Australian Sleep Disorders Reserach Institute
name: David Hillman, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
References: