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AutoSet for Her Clinical Trial Protocol

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Standard AutoSet algorithm
Modified AutoSet algorithm
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Efficacy, Subjective feedback, Preference

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • West Australian Sleep Disorders Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Unblinded Investigational Arm

Standard AutoSet algorithm

Modified AutoSet algorithm

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

Apnoea Hypopnoea Index (AHI)
Number of apnoeas and hypopnoeas per hour of sleep
Oxygen Desaturation Index (ODI)
Number of oxygen desaturations per hour of sleep

Secondary Outcome Measures

Sleep Efficacy
Sleep time divided by total time available for sleep
Wake After Sleep Onset Time
Time awake in minutes after initial sleep onset
Time Taken to Fall Asleep
Time in minutes taken to fall alseep
Number of Spontaneous Arousals
Number of spontaneous arousals occurring over the entire total sleep time
Number of Hypopnoeas
Total number of hypopnoeas occurring in the total sleep time
Number of Obstructive Apnoeas
Total number of obstructive apnoeas occurring in the total sleep time
Number of Central Apnoeas
Total number of central apnoeas occurring in the total sleep time
Oxygen Saturation
Oxygen saturation recorded in the total sleep time
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)
Number of Respiratory Event Related Arousals
Total number of respiratory event related arousals over the entire sleep period

Full Information

First Posted
April 1, 2013
Last Updated
February 6, 2017
Sponsor
ResMed
Collaborators
The University of Western Australia
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1. Study Identification

Unique Protocol Identification Number
NCT01826513
Brief Title
AutoSet for Her Clinical Trial Protocol
Official Title
AutoSet for Her Clinical Trial Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
Collaborators
The University of Western Australia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, Efficacy, Subjective feedback, Preference

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unblinded Investigational Arm
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard AutoSet algorithm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Modified AutoSet algorithm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Standard AutoSet algorithm
Intervention Description
An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.
Intervention Type
Device
Intervention Name(s)
Modified AutoSet algorithm
Other Intervention Name(s)
AutoSet for Her
Intervention Description
An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.
Primary Outcome Measure Information:
Title
Apnoea Hypopnoea Index (AHI)
Description
Number of apnoeas and hypopnoeas per hour of sleep
Time Frame
1 day
Title
Oxygen Desaturation Index (ODI)
Description
Number of oxygen desaturations per hour of sleep
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Sleep Efficacy
Description
Sleep time divided by total time available for sleep
Time Frame
1 day
Title
Wake After Sleep Onset Time
Description
Time awake in minutes after initial sleep onset
Time Frame
1 day
Title
Time Taken to Fall Asleep
Description
Time in minutes taken to fall alseep
Time Frame
1 day
Title
Number of Spontaneous Arousals
Description
Number of spontaneous arousals occurring over the entire total sleep time
Time Frame
1 day
Title
Number of Hypopnoeas
Description
Total number of hypopnoeas occurring in the total sleep time
Time Frame
1 day
Title
Number of Obstructive Apnoeas
Description
Total number of obstructive apnoeas occurring in the total sleep time
Time Frame
1 day
Title
Number of Central Apnoeas
Description
Total number of central apnoeas occurring in the total sleep time
Time Frame
1 day
Title
Oxygen Saturation
Description
Oxygen saturation recorded in the total sleep time
Time Frame
1 day
Title
Percentage of Total Sleep Time Spent in Each Sleep Stage
Description
Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)
Time Frame
1 day
Title
Number of Respiratory Event Related Arousals
Description
Total number of respiratory event related arousals over the entire sleep period
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Eastwood, MBBS FRACP
Organizational Affiliation
Centre for Sleep Science, University of Western Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Hillman, MBBS FRACP
Organizational Affiliation
West Australian Sleep Disorders Reserach Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Australian Sleep Disorders Research Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

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