Sleep Disorders Trial, Completed NCT00906958 Sponsor: ResMed Condition: Sleep Disorders
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total — 10 in each group. All 20 participants completed the study, with no drop-outs reported. The trial was comparing two different breathing devices used for sleep apnoea: the Nexus Flow Generator (a modified AutoSet device) and the VPAP Flow Generator 25. It was measuring how well each device controlled breathing disruptions during sleep, as well as how comfortable and satisfying participants found each device to use. The reported data shows that for the main (primary) measures, both devices produced similar results. The number of breathing pauses and partial blockages per hour of sleep — known as the Apnoea-Hypopnoea Index, or AHI — was reported as 1.69 events per hour with the Nexus device and 1.73 events per hour with the VPAP device. The number of times blood oxygen levels dropped per hour was 1.95 with the Nexus device and 1.68 with the VPAP device. For the secondary measures — which asked participants to rate their experience on a scale of 0 to 10 — the reported data shows that breathing comfort was rated 8.0 for the Nexus device and 7.0 for the VPAP device; sleep disturbance caused by the device was rated 9.5 and 8.0 respectively (where a higher score means less disturbance); and how refreshed participants felt in the morning was rated 9.0 for the Nexus device and 8.0 for the VPAP device. It is worth noting that this was a very small study with only 10 people per group, and no further statistical detail was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Sleep Disorders Trial, Completed

NCT00906958
Completed Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 80 years old
  • You have been using a CPAP machine set to automatic (AutoSet) mode for at least 6 months
  • You are currently using a ResMed brand mask with your CPAP machine

Who may not be able to join:

  • You are not able to sign a written consent form
  • You are not able to read or understand English (written or spoken)
  • You are using a Bilevel PAP machine (a breathing device that delivers two different levels of air pressure)
  • You are currently pregnant
  • You currently have an acute respiratory infection (such as a chest infection or severe cold)
  • You currently have a sinus infection, middle ear infection, or a hole in your eardrum
  • You have a collapsed lung or air trapped around the heart (confirm with trial site)
  • You have recently had a serious nosebleed that required medical treatment

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Completed
Phase
Not Applicable
Sponsor
ResMed
Registry
ClinicalTrials.gov
Start date
11 May 2009
Est. completion
15 June 2009

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Apnoea-Hypopnoea Index (AHI); Oxygen Desaturation Index

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov