Obstructive Sleep ApneaNCT06407999
Pressure Relief Algorithm Eval
A study testing Expiratory Pressure Relief in people with Obstructive Sleep Apnea, run by SleepRes Inc. at 1 site in United States.
Trial summary
The PRA Effect on APAP Therapy Pressure Study is a randomized, controlled, crossover study in PAP-adherent participants with OSA. Pre-screening is conducted to establish potential eligibility based on regular usage of > 4 hours/night on patients who use an APAP device with a PRA mode. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Expiratory Pressure Relief
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adherent use of ≥ four hours/night over previous 2 months.
- P95 ≥ 8 cmH2O.
Who cannot join
- Excessive alcohol consumption (>14 drinks/week).
- The use of any illegal drug(s).
- Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep Centers of Middle Tennessee
Murfreesboro, Tennessee, 37129
About this study
Official title: A Prospective, Randomized, Crossover Study on the Effect of Pressure Relief Algorithms (PRA) on Therapy Pressure in APAP Therapy for Obstructive Sleep Apnea (OSA)
The PRA Effect on APAP Therapy Pressure Study is a randomized, controlled, crossover study in PAP-adherent participants with OSA. Pre-screening is conducted to establish potential eligibility based on regular usage of > 4 hours/night on patients who use an APAP device with a PRA mode. Participants would then be recruited as described below. For those who sign an informed consent, they will be instructed to use the device for the next 8 days with the PRA turned on for four consecutive nights and off for four consecutive nights, but in random orientation. To make sure that the device is not limited to APAP range when adjusting to respond to PRA, the upper limit will be changed to 20 cmH2O during the study. Additionally, only patients who have a current P95 of 8 cmH2O or greater will be eligible so that the maximum PRA setting of 3 cmH2O can be used.
Read the detailed description
The first phase of recruiting for the PRA Effect on APAP Therapy Pressure Study will be done during a single phone contact following an email recruitment. During this call, participants will be explained the study along with risks and benefits and evaluated for inclusion and exclusion criteria. If the participant is eligible to enter the study, they will be sent an electronic Informed Consent Form to sign. Once the form is signed and verified, the study can then start that evening, after the participant's device has been set for the study.
During both arms of the study, every aspect of operation of the APAP devices will be the same as those the patient normally uses, except for the following three things:
- APAP upper range limit will be set to 20 cmH2O
- PRA or 3 cmH2O will be either on or off
- Participants cannot use a V̇-Com™ device. Participants will randomly be assigned to start with or without PRA. Once the settings are remotely assigned to the device, the patient will sleep on these settings for four nights, ideally consecutively.
After four nights, the PRA setting will be remotely switched to the 2nd arm setting (on or off), and median and P95 pressure, Usage, AHI, and Leak averaged over those four nights will be downloaded. The participant will then use the device with the new settings for an additional four nights, hopefully also sequentially.
Following the 2nd group of four nights, median and P95 pressure, Usage, AHI, and Leak averaged over those four nights will be downloaded, the participant will be informed that their involvement in the study is complete, and the device will be remotely set back to the settings it had prior to the study. Participants will then receive the compensation credit.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Expiratory Pressure Relief
- 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.
Expiratory Pressure ReliefDevice
Also called C-Flex, EPR
EPR is a function used in CPAP intended to improve comfort by reducing delivered pressure during the expiratory phase. When EPR is not used, the patient receives true CPAP.
| Study group | Role | What they receive |
|---|---|---|
| APAP w/ EPR On | Experimental | The patient will use their normal CPAP device and equipment in the normal operating mode but we will set EPR on if they do not already use it that way. Receives: Device: Expiratory Pressure Relief |
| APAP w/ EPR Off | Placebo comparator | The patient will use their normal CPAP device and equipment in the normal operating mode but we will set EPR off if they do not already use it that way. Receives: Device: Expiratory Pressure Relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
P95/P90
P95/P90 represent pressure levels that eliminate breathing obstructions for at least 90% to 95% of the sleep period
Measured: Averaged over every night for each 4-night arm
Secondary outcomes (3)
Leak
Leak measured by the device in excess of the required exhaust valve leak to purge CO2 from the breathing circuit.
Measured: Averaged over every night for each 4-night arm
Usage
Elapsed therapy usage time measured each night
Measured: Averaged over every night for each 4-night arm
AHI
Apnea/Hypopnea Index - Measurement of obstructive events averaged over the night in events per hour.
Measured: Averaged over every night for each 4-night arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Why it stopped: Funds were redirected to other projects with higher priority
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Participants will sleep at home with their normal CPAP (continuous positive airway pressure)/APAP (auto-adjusting...) equipment for 4 nights with EPR (expiratory pressure relief) on, the 4 nights with EPR off. The starting therapy will be randomized.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SleepRes Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William H Noah, MD, Study director, SleepRes, LLC., Sleep Centers of Middle Tennessee, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407999
- Sponsor's protocol ID
- Home 0002
- Status last verified
- Nov 2024
- First submitted
- 6 May 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only plan to publish results.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Crossover Study on the Effect of Pressure Relief Algorithms (PRA) on Therapy Pressure in APAP Therapy for Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT06407999
- Acronym / sponsor ID
- Home 0002
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funds were redirected to other projects with higher priority
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SleepRes Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PRA Effect on APAP Therapy Pressure Study is a randomized, controlled, crossover study in PAP-adherent participants with OSA. Pre-screening is conducted to establish potential eligibility based on regular usage of > 4 hours/night on patients who use an APAP device with a PRA mode. Participants would then be recruited as described below. For those who sign an informed consent, they will be instructed to use the device for the next 8 days with the PRA turned on for four consecutive nights and off for four consecutive nights, but in random orientation. To make sure that the device is not limited to APAP range when adjusting to respond to PRA, the upper limit will be changed to 20 cmH2O during the study. Additionally, only patients who have a current P95 of 8 cmH2O or greater will be eligible so that the maximum PRA setting of 3 cmH2O can be used.
Detailed description
The first phase of recruiting for the PRA Effect on APAP Therapy Pressure Study will be done during a single phone contact following an email recruitment. During this call, participants will be explained the study along with risks and benefits and evaluated for inclusion and exclusion criteria. If the participant is eligible to enter the study, they will be sent an electronic Informed Consent Form to sign. Once the form is signed and verified, the study can then start that evening, after the participant's device has been set for the study.
During both arms of the study, every aspect of operation of the APAP devices will be the same as those the patient normally uses, except for the following three things:
- APAP upper range limit will be set to 20 cmH2O
- PRA or 3 cmH2O will be either on or off
- Participants cannot use a V̇-Com™ device. Participants will randomly be assigned to start with or without PRA. Once the settings are remotely assigned to the device, the patient will sleep on these settings for four nights, ideally consecutively.
After four nights, the PRA setting will be remotely switched to the 2nd arm setting (on or off), and median and P95 pressure, Usage, AHI, and Leak averaged over those four nights will be downloaded. The participant will then use the device with the new settings for an additional four nights, hopefully also sequentially.
Following the 2nd group of four nights, median and P95 pressure, Usage, AHI, and Leak averaged over those four nights will be downloaded, the participant will be informed that their involvement in the study is complete, and the device will be remotely set back to the settings it had prior to the study. Participants will then receive the compensation credit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will sleep at home with their normal CPAP (continuous positive airway pressure)/APAP (auto-adjusting...) equipment for 4 nights with EPR (expiratory pressure relief) on, the 4 nights with EPR off. The starting therapy will be randomized.
| Arm | Type | Receives |
|---|---|---|
| APAP w/ EPR On | Experimental | Device: Expiratory Pressure ReliefThe patient will use their normal CPAP device and equipment in the normal operating mode but we will set EPR on if they do not already use it that way. |
| APAP w/ EPR Off | Placebo comparator | Device: Expiratory Pressure ReliefThe patient will use their normal CPAP device and equipment in the normal operating mode but we will set EPR off if they do not already use it that way. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adherent use of ≥ four hours/night over previous 2 months.
- P95 ≥ 8 cmH2O.
Key exclusion criteria (3 listed)
- Excessive alcohol consumption (>14 drinks/week).
- The use of any illegal drug(s).
- Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
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 |
|---|---|---|
| Expiratory Pressure ReliefAlso: C-Flex, EPREPR is a function used in CPAP intended to improve comfort by reducing delivered pressure during the expiratory phase. When EPR is not used, the patient receives true CPAP. | Device | APAP w/ EPR Off, APAP w/ EPR On |
Primary outcome
P95/P90
Time frame: Averaged over every night for each 4-night arm
P95/P90 represent pressure levels that eliminate breathing obstructions for at least 90% to 95% of the sleep period
3 secondary outcomes
Leak
Time frame: Averaged over every night for each 4-night arm
Usage
Time frame: Averaged over every night for each 4-night arm
AHI
Time frame: Averaged over every night for each 4-night arm
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No. Only plan to publish results.
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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.
William H Noah, MD study director
SleepRes, LLC., Sleep Centers of Middle Tennessee, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory Pressure Relief in people with Obstructive Sleep Apnea, run by SleepRes Inc. at 1 site in United States.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 7 Nov 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
P95/P90 (time frame: Averaged over every night for each 4-night arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2024.