Obstructive Sleep ApneaNCT06238362
TheraPAP Equivalence Crossover Study
A study testing TPAP and CPAP in people with Obstructive Sleep Apnea, run by SleepRes Inc. at 1 site in United States.
Trial summary
The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA. 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?
- TPAP and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to 8 Jul 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI > 10 on a previous PSG.
- CPAP adherence for an average of 5 h/night in the 2 months before the study
- BMI above 18 kg/m2, inclusive.
Who cannot join
- Current clinically significant sleep disorder other than OSA of a severity that would interfere with study participation or interpretability of data (including central sleep apnea, per central AHI > 5 events/h).
- Current clinically unstable cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or poorly controlled hypertension (>140/90mmHg).
- Current clinically significant neurological disorder, including epilepsy/convulsions.
- Other serious major organ system disease including renal failure, lung disease, neuromuscular disease, or liver disease.
- Schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) or International Classification of Disease tenth edition criteria.
- Attempted suicide within 1 year prior to screening, or current suicidal ideation.
Show all 13Show fewer
- History of substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.
- A serious illness or infection in the past 30 days as determined by investigator.
- Clinically significant cognitive dysfunction as determined by investigator.
- Chronic oxygen therapy.
- Patients with hypoglossal nerve stimulation implant.
- Any non-previously mentioned vulnerable population.
- 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
SleepCenters of Middle Tennessee
Clarksville, Tennessee, 37043
About this study
Official title: Randomized Crossover Study to Compare Effectiveness of a Device Providing Pressure Drops During Inspiration (TPAP) to Continuous Positive Airway Pressure (CPAP) in Obstructive Sleep Apnea (OSA)
The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.
Read the detailed description
The TheraEquivalence Study is a randomized, controlled, crossover study in participants with OSA. A split-night polysomnogram (PSG) will be conducted on CPAP and TPAP (3.5 h each treatment arm) in previously diagnosed OSA patients, to test the effectiveness of TPAP vs. CPAP. The sequence of periods for each participant are assigned in random order. Therapeutic CPAP level will be defined based on each individual's pressure levels from their currently used APAP device deemed to eliminate breathing obstructions for at least 90/95% of the sleep period (P90/P95) + 1 cmH2O (cm of water pressure). P90/P95 will be defined based on the previous 2 months of adherent Auto-adjusted Positive Airway Pressure (APAP) usage (defined as averaging > 5 hrs/night). On TPAP Tthe pressure drop during inspiration is generally done in two steps and varies, as outlined in table 1, based on the set pressure level, with larger drops occurring when the set pressure is higher. However, the pressure never goes below 5 cm H20. This lower pressure is returned to the set pressure level about halfway through expiration. These pressure drops are designed to make TPAP considerably more comfortable than CPAP.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- TPAP, CPAP
- 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.
TPAPOther
Also called TheraPAP
Algorithm for modification of CPAP therapy where pressure is reduced during the inspiratory phase though much of the expiratory phase, then is returned to full pressure near the end of the expiratory phase. Note that the same device that delivers CPAP can also deliver TPAP
CPAPDevice
Gold standard for treating sleep apnea.
| Study group | Role | What they receive |
|---|---|---|
| TPAP - Experimental Therapy | Experimental | Experimental therapy in which pressure is reduced during inspiration and the reduction is carried through part of expiration such that the pressure is increased near the end of expiration. Receives: Other: TPAP |
| CPAP - Traditional OSA Therapy | Active comparator | Standard OSA therapy to which the TPAP therapy will be compared for efficacy. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/Hypopnea Index
Gold standard measure of CPAP therapy efficacy. Scored as number of respiratory events per hour of sleep. The device is considered efficacious with an apnea-hypopnea index < 5 events/h.
Measured: During overnight procedure, on average 3.5 hours for each intervention
Secondary outcomes (5)
REM Apnea/Hypopnea Index (AHI)
Scored as number of respiratory events per hour of sleep spent in rapid eye movement stage. The device is generally considered efficacious with an apnea-hypopnea index in REM < 5 events/h, however it has to be noted that obstructive sleep apnea during REM sleep is more difficult to treat.
Measured: During rapid eye movements (REM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention
Supine AHI
Assessment of AHI (apnea hypopnea index) during supine sleep. The device is generally considered efficacious if supine AHI is below 5 events/h, however it has to be noted that obstructive sleep apnea in supine position is more difficult to treat.
Measured: During sleep spent in supine position during the overnight procedure, assessed over 3.5 hours for each intervention
Unintentional Patient Circuit Leak
Evaluation of unintentional circuit leak by measuring flow offset from CPAP and knowing the intentional mask leak
Measured: During overnight procedure
NREM Apnea/Hypopnea Index (AHI)
Scored as number of respiratory events per hour of sleep spent in non-rapid eye movement stage (NREM). The device is generally considered efficacious with an apnea-hypopnea index in NREM < 5 events/h.
Measured: During non-rapid eye movements (NREM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention
Lateral AHI
Assessment of AHI (apnea hypopnea index) during lateral sleep. The device is generally considered efficacious if lateral AHI is below 5 events/h
Measured: During sleep spent in lateral position during the overnight procedure, assessed over 3.5 hours for each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start7 Mar 2024
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
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
- Model description
- Patients will be treated with both the interventional therapy and standard CPAP therapy in one night to compare efficacy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- SleepRes Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abinash Joshi, MD, Principal investigator, SleepRes Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238362
- Sponsor's protocol ID
- TheraEquivalence
- Status last verified
- Nov 2024
- First submitted
- 17 Jan 2024
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover Study to Compare Effectiveness of a Device Providing Pressure Drops During Inspiration (TPAP) to Continuous Positive Airway Pressure (CPAP) in Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT06238362
- Acronym / sponsor ID
- TheraEquivalence
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SleepRes Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.
Detailed description
The TheraEquivalence Study is a randomized, controlled, crossover study in participants with OSA. A split-night polysomnogram (PSG) will be conducted on CPAP and TPAP (3.5 h each treatment arm) in previously diagnosed OSA patients, to test the effectiveness of TPAP vs. CPAP. The sequence of periods for each participant are assigned in random order. Therapeutic CPAP level will be defined based on each individual's pressure levels from their currently used APAP device deemed to eliminate breathing obstructions for at least 90/95% of the sleep period (P90/P95) + 1 cmH2O (cm of water pressure). P90/P95 will be defined based on the previous 2 months of adherent Auto-adjusted Positive Airway Pressure (APAP) usage (defined as averaging > 5 hrs/night). On TPAP Tthe pressure drop during inspiration is generally done in two steps and varies, as outlined in table 1, based on the set pressure level, with larger drops occurring when the set pressure is higher. However, the pressure never goes below 5 cm H20. This lower pressure is returned to the set pressure level about halfway through expiration. These pressure drops are designed to make TPAP considerably more comfortable than CPAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be treated with both the interventional therapy and standard CPAP therapy in one night to compare efficacy.
| Arm | Type | Receives |
|---|---|---|
| TPAP - Experimental Therapy | Experimental | Other: TPAPExperimental therapy in which pressure is reduced during inspiration and the reduction is carried through part of expiration such that the pressure is increased near the end of expiration. |
| CPAP - Traditional OSA Therapy | Active comparator | Device: CPAPStandard OSA therapy to which the TPAP therapy will be compared for efficacy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AHI > 10 on a previous PSG.
- CPAP adherence for an average of 5 h/night in the 2 months before the study
- BMI above 18 kg/m2, inclusive.
Key exclusion criteria (13 listed)
- Current clinically significant sleep disorder other than OSA of a severity that would interfere with study participation or interpretability of data (including central sleep apnea, per central AHI > 5 events/h).
- Current clinically unstable cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or poorly controlled hypertension (>140/90mmHg).
- Current clinically significant neurological disorder, including epilepsy/convulsions.
- Other serious major organ system disease including renal failure, lung disease, neuromuscular disease, or liver disease.
- Schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) or International Classification of Disease tenth edition criteria.
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 |
|---|---|---|
| TPAPAlso: TheraPAPAlgorithm for modification of CPAP therapy where pressure is reduced during the inspiratory phase though much of the expiratory phase, then is returned to full pressure near the end of the expiratory phase. Note that the same device that delivers CPAP can also deliver TPAP | Other | TPAP - Experimental Therapy |
| CPAPGold standard for treating sleep apnea. | Device | CPAP - Traditional OSA Therapy |
Primary outcome
Apnea/Hypopnea Index
Time frame: During overnight procedure, on average 3.5 hours for each intervention
Gold standard measure of CPAP therapy efficacy. Scored as number of respiratory events per hour of sleep. The device is considered efficacious with an apnea-hypopnea index < 5 events/h.
5 secondary outcomes
REM Apnea/Hypopnea Index (AHI)
Time frame: During rapid eye movements (REM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention
Supine AHI
Time frame: During sleep spent in supine position during the overnight procedure, assessed over 3.5 hours for each intervention
Unintentional Patient Circuit Leak
Time frame: During overnight procedure
NREM Apnea/Hypopnea Index (AHI)
Time frame: During non-rapid eye movements (NREM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention
Lateral AHI
Time frame: During sleep spent in lateral position during the overnight procedure, assessed over 3.5 hours for each intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Abinash Joshi, MD principal investigator
SleepRes Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPAP and CPAP 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 3 inclusion and 13 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 29 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. 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 29 Nov 2024). 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?
Apnea/Hypopnea Index (time frame: During overnight procedure, on average 3.5 hours for each intervention). 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 29 Nov 2024.