AutoSet for Her Clinical Trial Protocol

Study Overview
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Brief Summary
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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.

Official Title
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AutoSet for Her Clinical Trial Protocol

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Standard AutoSet algorithm
* Device: Modified AutoSet algorithm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unblinded Investigational Arm<br>Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase). | Device: Modified AutoSet algorithm<br>* An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.<br>* Other names: AutoSet for Her;|
| Active Comparator: Standard AutoSet algorithm<br>Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night. | Device: Standard AutoSet algorithm<br>* An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.<br>Device: Modified AutoSet algorithm<br>* An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.<br>* Other names: AutoSet for Her;|
| Experimental: Modified AutoSet algorithm<br>Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night. | Device: Standard AutoSet algorithm<br>* An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.<br>Device: Modified AutoSet algorithm<br>* An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.<br>* Other names: AutoSet for Her;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnoea Hypopnoea Index (AHI) | Number of apnoeas and hypopnoeas per hour of sleep | 1 day | 
| Oxygen Desaturation Index (ODI) | Number of oxygen desaturations per hour of sleep | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficacy | Sleep time divided by total time available for sleep | 1 day | 
| Wake After Sleep Onset Time | Time awake in minutes after initial sleep onset | 1 day | 
| Time Taken to Fall Asleep | Time in minutes taken to fall alseep | 1 day | 
| Number of Spontaneous Arousals | Number of spontaneous arousals occurring over the entire total sleep time | 1 day | 
| Number of Hypopnoeas | Total number of hypopnoeas occurring in the total sleep time | 1 day | 
| Number of Obstructive Apnoeas | Total number of obstructive apnoeas occurring in the total sleep time | 1 day | 
| Number of Central Apnoeas | Total number of central apnoeas occurring in the total sleep time | 1 day | 
| Oxygen Saturation | Oxygen saturation recorded in the total sleep time | 1 day | 
| Percentage of Total Sleep Time Spent in Each Sleep Stage | Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM) | 1 day | 
| Number of Respiratory Event Related Arousals | Total number of respiratory event related arousals over the entire sleep period | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea, Efficacy, Subjective feedback, Preference