PEEP Guard 90-Day Results Guarantee

1. Eligibility

The Results Guarantee is available only to patients who:

• purchase the PEEP Guard Complete treatment package;
• complete the required baseline monitoring;
• proceed with fitting and use of their PEEP Guard;
• attend the prescribed follow-up and optimisation consultations;
• reasonably participate in recommended optimisation of their PEEP Guard;
• complete the required post-optimisation monitoring; and
• satisfy the measurement and compliance requirements described below.

The Results Guarantee does not apply to the PEEP Guard Essential treatment package.

2. Baseline measurement

Before commencing PEEP Guard therapy, the patient will complete three consecutive valid nights of pre-treatment overnight oximetry using the monitoring system supplied or approved by iHeart Sleep.

The Baseline ODI will be calculated as the arithmetic mean of the ODI recorded across these three valid baseline nights.

If a recording is invalid, incomplete or of insufficient quality to permit reliable ODI assessment, that recording will not be included and must be repeated.

The intention is to obtain three consecutive valid baseline recordings. An invalid recording does not constitute one of the three qualifying nights.

3. Treatment and optimisation

Following fitting of PEEP Guard, treatment will be reviewed and optimised as clinically appropriate.

The patient must attend the prescribed follow-up consultation(s) and reasonably participate in recommended adjustments or optimisation.

The final Results Guarantee assessment will take place only after the treating clinician considers that reasonable optimisation of PEEP Guard therapy has been completed.

4. Objective verification of PEEP Guard use

PEEP Guard Complete incorporates objective compliance monitoring capable of recording periods of PEEP Guard use.

This information is used to establish whether post-treatment oximetry recordings correspond with periods during which PEEP Guard was actually being worn.

For a post-treatment oximetry recording to qualify for the Results Guarantee assessment, the oximetry recording must correspond with the objective PEEP Guard compliance record sufficiently to allow the treatment response to be accurately analysed.

A recording that cannot be adequately matched with the compliance record will not be treated as evidence that treatment has succeeded or failed. Instead, the recording will be considered non-qualifying and may need to be repeated.

5. Post-optimisation measurement

Once PEEP Guard therapy has been optimised, the patient will complete three consecutive valid nights of overnight oximetry while using their optimised PEEP Guard.

Each qualifying treatment recording must:

• be valid and of sufficient quality to permit ODI assessment;
• be performed using the monitoring methodology specified by iHeart Sleep; and
• correspond with the objective PEEP Guard compliance record sufficiently to permit accurate analysis of the treatment period.

The Treatment ODI will be calculated as the arithmetic mean of the ODI results from the three qualifying post-optimisation nights.

Where a recording is invalid or cannot be adequately matched with the compliance record, it will not constitute one of the three qualifying nights and must be repeated as required.

6. Consistent measurement methodology

The Results Guarantee assesses the change in ODI between pre-treatment baseline and optimised PEEP Guard therapy.

To provide a consistent comparison, baseline and post-treatment measurements will use, as far as reasonably practicable:

• the same overnight oximetry monitoring system;
• the same ODI definition;
• the same desaturation criteria;
• the same analysis methodology;
• three consecutive valid overnight recordings; and
• the arithmetic mean of the three qualifying ODI results.

This methodology is intended to provide a consistent within-patient comparison of treatment response.

Overnight oximetry performed for the Results Guarantee is not represented as a substitute for a formal diagnostic sleep study.

7. Treatment-response criteria

PEEP Guard therapy will be considered to have achieved the treatment outcome under the Results Guarantee if either of the following criteria is satisfied:

Criterion A — 50% reduction

The mean Treatment ODI is at least 50% lower than the mean Baseline ODI.

ODI reduction (%) = (Baseline ODI − Treatment ODI) ÷ Baseline ODI × 100

OR

Criterion B — ODI below 10

The mean Treatment ODI is below 10 events per hour.

Only one of these two criteria needs to be achieved for the treatment to satisfy the Results Guarantee outcome.

8. When a refund applies

If, following reasonable optimisation of PEEP Guard therapy:

• the mean Treatment ODI has not been reduced by at least 50% compared with the mean Baseline ODI; and
• the mean Treatment ODI is not below 10 events per hour;

the patient will be eligible for the Results Guarantee refund, provided all other requirements of these Terms & Conditions have been satisfied.

The refund is the patient’s actual out-of-pocket cost for the PEEP Guard device component of treatment, up to a maximum of $1,495.

“Out-of-pocket” means the amount the patient has paid iHeart Sleep and not recovered, or become entitled to recover, from a private health fund or any other third party. Where a health fund has paid a benefit toward the device, the refund is reduced by that benefit, so that the refund never exceeds what the patient has actually paid. Where a refund would require a health fund claim to be reversed or adjusted, iHeart Sleep will do so and the refund will be calculated accordingly.

The remaining component of the PEEP Guard Complete treatment fee relates to consultations, records, clinical assessment, monitoring, optimisation and other services already provided and is not part of the Results Guarantee refund.

9. Return of PEEP Guard

Where a Results Guarantee refund is approved, the PEEP Guard device must be returned to iHeart Sleep.

The device refund will be processed following return of the PEEP Guard, subject to these Terms & Conditions.

Returning the device also allows iHeart Sleep to examine unsuccessful treatments and use that information to improve the treatment process.

10. Monitoring equipment

Any oximetry equipment supplied on loan or rental remains the property of iHeart Sleep unless the patient elects to purchase it under an available purchase option.

Loan or rental monitoring equipment must be returned at the end of the monitoring period or when requested by iHeart Sleep.

If a patient has validly purchased the monitoring equipment, it does not need to be returned as part of a Results Guarantee claim.

11. 90-day treatment period

The treatment, optimisation and monitoring program is intended to occur over approximately 90 days.

Patients are expected to reasonably participate in the treatment and monitoring program during this period.

A patient will not lose eligibility solely because completion of the assessment extends beyond 90 days due to reasonable clinical, technical, logistical or administrative circumstances outside the patient’s control.

12. Invalid or unsuccessful recordings

A technically invalid recording, inadequate recording, equipment failure or recording that cannot be adequately matched to the PEEP Guard compliance record will not be classified as either a successful or unsuccessful treatment night.

The recording may instead be repeated so that sufficient valid data are available to make the comparison required under the Results Guarantee.

This requirement is intended to ensure that treatment outcome is determined from valid, objectively verifiable data rather than from incomplete or unreliable recordings.

13. Purpose of the Results Guarantee

The Results Guarantee relates specifically to the objective ODI treatment-response criteria described in these Terms & Conditions.

It does not guarantee:

• elimination of sleep apnoea or other sleep-disordered breathing;
• elimination of all oxygen desaturations;
• elimination of snoring or other symptoms;
• achievement of any particular AHI;
• any particular subjective improvement in sleep or daytime symptoms; or
• that additional medical investigation or treatment will not be required.

Where clinically appropriate, patients may be advised to discuss their results with their medical practitioner or undergo further investigation or formal sleep testing.

14. Australian Consumer Law

The PEEP Guard 90-Day Results Guarantee is an additional benefit offered with eligible PEEP Guard Complete treatment.

Nothing in these Terms & Conditions is intended to exclude, restrict or modify any consumer guarantee, right or remedy that cannot lawfully be excluded under the Australian Consumer Law or other applicable legislation.

Any rights available under the PEEP Guard Results Guarantee are in addition to any rights the patient may otherwise have under applicable law.

Questions about the Results Guarantee

Dr Chris Hart

iHeart Sleep Research Pty Ltd

Phone 0458 914 390

info@iheartsleep.com