Obstructive Sleep ApneaNCT01826513

AutoSet for Her Clinical Trial Protocol

A study testing Standard AutoSet algorithm and Modified AutoSet algorithm in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: Standard AutoSet algorithm and Modified AutoSet algorithm
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteAustralia
Study dates: May 2013to Jun 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

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

Other trials in Australia

About this study

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.

Conditions: Obstructive Sleep Apnea
Being tested: Standard AutoSet algorithm, Modified AutoSet algorithm
Keywords: Obstructive sleep apnea, Efficacy, Subjective feedback, Preference
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard AutoSet algorithmDevice
An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.
Modified AutoSet algorithmDevice
Also called AutoSet for Her
An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.

Study groups in NCT01826513
Study group	Role	What they receive
Unblinded Investigational Arm	Experimental	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). Receives: Device: Modified AutoSet algorithm
Standard AutoSet algorithm	Active comparator	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. Receives: Device: Standard AutoSet algorithm; Device: Modified AutoSet algorithm
Modified AutoSet algorithm	Experimental	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. Receives: Device: Standard AutoSet algorithm; Device: Modified AutoSet algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

Sleep Efficacy
Sleep time divided by total time available for sleep
Measured: 1 day
Wake After Sleep Onset Time
Time awake in minutes after initial sleep onset
Measured: 1 day
Time Taken to Fall Asleep
Time in minutes taken to fall alseep
Measured: 1 day
Number of Spontaneous Arousals
Number of spontaneous arousals occurring over the entire total sleep time
Measured: 1 day
Number of Hypopnoeas
Total number of hypopnoeas occurring in the total sleep time
Measured: 1 day
Number of Obstructive Apnoeas
Total number of obstructive apnoeas occurring in the total sleep time
Measured: 1 day
Number of Central Apnoeas
Total number of central apnoeas occurring in the total sleep time
Measured: 1 day
Oxygen Saturation
Oxygen saturation recorded in the total sleep time
Measured: 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)
Measured: 1 day
Number of Respiratory Event Related Arousals
Total number of respiratory event related arousals over the entire sleep period
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Jun 2013

First posted8 Apr 2013 (estimated)
Study startMay 2013
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01826513
Sponsor's protocol ID: MA13245678
Status last verified: Feb 2017
First submitted: 1 Apr 2013
Last updated: 27 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Myofunctional Therapy for Obstructive Sleep Apnea
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A Study of the Sleepnet Elara APAP Device
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Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
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Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse
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The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
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All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AutoSet for Her Clinical Trial Protocol
ClinicalTrials.gov ID: NCT01826513
Acronym / sponsor ID: MA13245678
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea, Efficacy, Subjective feedback, Preference
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: ResMedIndustry (pharma, biotech, devices)
Collaborators: The University of Western Australia
Study start: May 2013
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 8 Apr 2013 (estimated)
Results: Posted 27 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Unblinded Investigational Arm	Experimental	Device: Modified AutoSet algorithmParticipants 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).
Standard AutoSet algorithm	Active comparator	Device: Standard AutoSet algorithm, Device: Modified AutoSet algorithmParticipants 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.
Modified AutoSet algorithm	Experimental	Device: Standard AutoSet algorithm, Device: Modified AutoSet algorithmParticipants 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.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard AutoSet algorithmAn AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.	Device	Modified AutoSet algorithm, Standard AutoSet algorithm
Modified AutoSet algorithmAlso: AutoSet for HerAn AutoSet device with an algorithm developed for sleep breathing parameters specific to females.	Device	Modified AutoSet algorithm, Standard AutoSet algorithm, Unblinded Investigational Arm

Primary outcome

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

10 secondary outcomes

Sleep Efficacy
Time frame: 1 day
Wake After Sleep Onset Time
Time frame: 1 day
Time Taken to Fall Asleep
Time frame: 1 day
Number of Spontaneous Arousals
Time frame: 1 day
Number of Hypopnoeas
Time frame: 1 day
Number of Obstructive Apnoeas
Time frame: 1 day
Number of Central Apnoeas
Time frame: 1 day
Oxygen Saturation
Time frame: 1 day
Percentage of Total Sleep Time Spent in Each Sleep Stage
Time frame: 1 day
Number of Respiratory Event Related Arousals
Time frame: 1 day

Results and safety

Results posted to the registry on 27 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Unblinded Investigational Arm	5	5
Standard AutoSet Algorithm	10	10
Modified AutoSet Then Standard AutoSet	10	10

Primary outcome: Apnoea Hypopnoea Index (AHI)

Time frame: 1 day. Mean (Standard Deviation). Unit: events/hour

Measure	Standard AutoSet Algorithm n = 20	Modified AutoSet Algorithm n = 20
Value	0.96 (1.40)	0.91 (0.90)

Population analysed: Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.

Primary outcome: Oxygen Desaturation Index (ODI)

Time frame: 1 day. Mean (Standard Deviation). Unit: events/hour

Measure	Standard AutoSet Algorithm n = 20	Modified AutoSet Algorithm n = 20
Value	1.92 (1.82)	2.19 (2.15)

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Unblinded Investigational Arm	0 of 5 (0%)	0 of 5 (0%)	Not reported
Standard AutoSet Algorithm	0 of 10 (0%)	0 of 10 (0%)	Not reported
Modified AutoSet Then Standard AutoSet	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obstructive Sleep Apnea

Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
A Study of the Sleepnet Elara APAP Device
Sleep Apnea - Obstructive
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
Not yet recruiting
Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse
Obstructive Sleep Apnea
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Eastwood, MBBS FRACP principal investigator

Centre for Sleep Science, University of Western Australia

David Hillman, MBBS FRACP principal investigator

West Australian Sleep Disorders Reserach Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standard AutoSet algorithm and Modified AutoSet algorithm in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apnoea Hypopnoea Index (AHI) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01826513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.