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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Modified AutoSet algorithm; Device: Standard AutoSet algorithm

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • West Australian Sleep Disorders Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unblinded Investigational Arm; 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; An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.; Other Names: AutoSet for Her
Active Comparator: 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.	Device: Modified AutoSet algorithm; An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.; Other Names: AutoSet for Her; Device: Standard AutoSet algorithm; An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.
Experimental: 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.	Device: Modified AutoSet algorithm; An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.; Other Names: AutoSet for Her; Device: Standard AutoSet algorithm; An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: The University of Western Australia
• Investigators: Principal Investigator: Peter Eastwood, MBBS FRACP, Centre for Sleep Science, University of Western Australia; Principal Investigator: David Hillman, MBBS FRACP, West Australian Sleep Disorders Reserach Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 1, 2013
• First Submitted That Met QC Criteria: April 3, 2013
• First Posted (Estimate): April 8, 2013

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Efficacy; Preference; Subjective feedback
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: MA13245678