AutoSet for Her Clinical Trial Protocol

Not Applicable

Completed

Conditions: Obstructive Sleep Apnea

Interventions: Device: Standard AutoSet algorithm
Device: Modified AutoSet algorithm

Registration Number: NCT01826513

Lead Sponsor: ResMed

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Modified AutoSet algorithm	Modified AutoSet algorithm	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.
Modified AutoSet algorithm	Standard AutoSet algorithm	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.
Standard AutoSet algorithm	Standard AutoSet algorithm	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.
Standard AutoSet algorithm	Modified AutoSet algorithm	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.
Unblinded Investigational Arm	Modified AutoSet algorithm	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).

Primary Outcome Measures

Name	Time	Method
Apnoea Hypopnoea Index (AHI)	1 day	Number of apnoeas and hypopnoeas per hour of sleep
Oxygen Desaturation Index (ODI)	1 day	Number of oxygen desaturations per hour of sleep

Secondary Outcome Measures

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