Treatment for Obstructive Sleep ApneaNCT04029311
Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
A study testing Nuance Pro, autoPAP and TAP PAP in people with Treatment for Obstructive Sleep Apnea, run by Joseph Adame at 1 site in United States.
Trial summary
To study the effects of two combination therapies for patients with obstructive sleep apnea (OSA) who have been both intolerant to Positive Airway Pressure (PAP) therapy and sub-therapeutic to oral appliance therapy. Hypothesis 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Treatment for Obstructive Sleep Apnea
- What is being tested?
- Nuance Pro, autoPAP and TAP PAP
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2017to 7 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Baseline diagnosis AHI > or = 5 plus ESS . or = 10.
- PAP Intolerance
- Partial Response to oral appliance therapy: AHI > 5
- Age: > 18 Exclusion Criteria: History of daily use of alcohol, narcotics or Central Nervous System (CNS) depressants.
- Diagnosis of Central Sleep Apnea
- Pregnancy
- Edentulous
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
To study the effects of two combination therapies for patients with obstructive sleep apnea (OSA) who have been both intolerant to Positive Airway Pressure (PAP) therapy and sub-therapeutic to oral appliance therapy.
Hypothesis
- There is a difference between Continuous Positive Airway Pressure (CPAP) vs CPAP/Oral Appliance (OA) connect vs CPAP/OA disconnected in terms of:
- Apnea Hypopnea Index (AHI) reduction
- Amount of side effects
- Amount of Leaks
- Hours of use (compliance)
- CPAP pressure
- There is a difference between connected and disconnected for the following symptoms:
- Epworth sleepiness Scale (ESS)
- Functional Outcomes of Sleep Questionnaire (FOSQ)
- Side effects Study Design - randomized prospective parallel
- Conditions
- Treatment for Obstructive Sleep Apnea
- Being tested
- Nuance Pro, autoPAP, TAP PAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuance ProDevice
Also called TAP PAP
Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP
autoPAPDevice
autoPAP
TAP PAPDevice
TAP PAP
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy with Preferred Mask | Experimental | Preferred Mask refers to a type of existing medical mask used for PAP therapy. Receives: Device: Nuance Pro; Device: autoPAP |
| Combination Therapy with Custom Mask | Experimental | Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. Receives: Device: autoPAP; Device: TAP PAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index
Episodes per hour that the patient experiences apneas and/or hypopneas
Measured: 2 months
PAP Pressure
The pressure required to treat the patient successfully
Measured: 2 months
Leaks
The Liters/Minute of leaking of the PAP machine
Measured: 2 months
Hours of Use
The average hours of use per night of each of the combination therapies
Measured: 2 months
Epworth Sleepiness Scale (ESS)
The ESS is a self-administered questionnaire with 8 questions. The score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life.
Measured: 2 months
Functional Outcomes Sleep Questionnaire (FOSQ)
FOSQ is a disease specific quality of life questionnaire to determine how sleepiness interferes one's quality of life. The total score range from 5 to 20 (10 questions, 1-4 points per each). The lower values represent a worse quality of life.
Measured: 2 months
Intolerance Questionnaire
This questionnaire consists of 4 questions to determine the frequency of 4 typical side-effects from positive airway pressure therapy. The score ranges from 0 to 16 (4 questions, 0-4 points per each). The higher value represent worse side effects.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start8 Jun 2017
- Primary completion6 Feb 2019
- Study completion7 May 2019
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 Treatment 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Adame
- Responsible party
- Sponsor-investigator, Joseph Adame, Adame, J. Michael, D.D.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029311
- Sponsor's protocol ID
- 20170991
- Status last verified
- Mar 2021
- First submitted
- 19 Jul 2019
- Last updated
- 2 Apr 2021
- 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 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT04029311
- Acronym / sponsor ID
- 20170991
- Conditions
- Treatment for Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Joseph Adame
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Posted 2 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effects of two combination therapies for patients with obstructive sleep apnea (OSA) who have been both intolerant to Positive Airway Pressure (PAP) therapy and sub-therapeutic to oral appliance therapy.
Hypothesis
- There is a difference between Continuous Positive Airway Pressure (CPAP) vs CPAP/Oral Appliance (OA) connect vs CPAP/OA disconnected in terms of:
- Apnea Hypopnea Index (AHI) reduction
- Amount of side effects
- Amount of Leaks
- Hours of use (compliance)
- CPAP pressure
- There is a difference between connected and disconnected for the following symptoms:
- Epworth sleepiness Scale (ESS)
- Functional Outcomes of Sleep Questionnaire (FOSQ)
- Side effects Study Design - randomized prospective parallel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy with Preferred Mask | Experimental | Device: Nuance Pro, Device: autoPAPPreferred Mask refers to a type of existing medical mask used for PAP therapy. |
| Combination Therapy with Custom Mask | Experimental | Device: autoPAP, Device: TAP PAPCustom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Nuance ProAlso: TAP PAPStudy compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP | Device | Combination Therapy with Preferred Mask |
| autoPAPautoPAP | Device | Combination Therapy with Custom Mask, Combination Therapy with Preferred Mask |
| TAP PAPTAP PAP | Device | Combination Therapy with Custom Mask |
Primary outcome
Apnea-Hypopnea Index
Time frame: 2 months
Episodes per hour that the patient experiences apneas and/or hypopneas
PAP Pressure
Time frame: 2 months
The pressure required to treat the patient successfully
Leaks
Time frame: 2 months
The Liters/Minute of leaking of the PAP machine
Hours of Use
Time frame: 2 months
The average hours of use per night of each of the combination therapies
Epworth Sleepiness Scale (ESS)
Time frame: 2 months
The ESS is a self-administered questionnaire with 8 questions. The score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life.
Functional Outcomes Sleep Questionnaire (FOSQ)
Time frame: 2 months
FOSQ is a disease specific quality of life questionnaire to determine how sleepiness interferes one's quality of life. The total score range from 5 to 20 (10 questions, 1-4 points per each). The lower values represent a worse quality of life.
Intolerance Questionnaire
Time frame: 2 months
This questionnaire consists of 4 questions to determine the frequency of 4 typical side-effects from positive airway pressure therapy. The score ranges from 0 to 16 (4 questions, 0-4 points per each). The higher value represent worse side effects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Treatment for Obstructive Sleep Apnea
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuance Pro, autoPAP and TAP PAP in people with Treatment for Obstructive Sleep Apnea, run by Joseph Adame 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?
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 2 Apr 2021. 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 2 Apr 2021). 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: 2 months). The study lists 7 primary outcomes in all. 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 2 Apr 2021.