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出境医 / 临床实验 / Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
Study Description
Brief 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. 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
2. 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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Treatment for Obstructive Sleep Apnea | Device: Nuance Pro Device: autoPAP Device: TAP PAP | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 28 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA) |
| Actual Study Start Date : | June 8, 2017 |
| Actual Primary Completion Date : | February 6, 2019 |
| Actual Study Completion Date : | May 7, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Combination Therapy with Preferred Mask
Preferred Mask refers to a type of existing medical mask used for PAP therapy.
|
Device: Nuance Pro
Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP
Other Name: TAP PAP
Device: autoPAP autoPAP
|
|
Experimental: Combination Therapy with Custom Mask
Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance.
|
Device: autoPAP
autoPAP
Device: TAP PAP TAP PAP
|
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Locations
| United States, Texas | |
| J. Michael Adame, DDS, PA | |
| Edinburg, Texas, United States, 78539 | |
Sponsors and Collaborators
Joseph Adame
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 19, 2019 | ||||||
| First Posted Date ICMJE | July 23, 2019 | ||||||
| Results First Submitted Date ICMJE | February 9, 2021 | ||||||
| Results First Posted Date ICMJE | April 2, 2021 | ||||||
| Last Update Posted Date | April 2, 2021 | ||||||
| Actual Study Start Date ICMJE | June 8, 2017 | ||||||
| Actual Primary Completion Date | February 6, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA) | ||||||
| Official Title ICMJE | Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA) | ||||||
| Brief 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. There is a difference between Continuous Positive Airway Pressure (CPAP) vs CPAP/Oral Appliance (OA) connect vs CPAP/OA disconnected in terms of:
2. There is a difference between connected and disconnected for the following symptoms:
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| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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| Condition ICMJE | Treatment for Obstructive Sleep Apnea | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
28 | ||||||
| Original Actual Enrollment ICMJE |
30 | ||||||
| Actual Study Completion Date ICMJE | May 7, 2019 | ||||||
| Actual Primary Completion Date | February 6, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: Baseline diagnosis AHI > or = 5 plus ESS . or = 10.
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04029311 | ||||||
| Other Study ID Numbers ICMJE | 20170991 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Joseph Adame, Adame, J. Michael, D.D.S. | ||||||
| Study Sponsor ICMJE | Joseph Adame | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Adame, J. Michael, D.D.S. | ||||||
| Verification Date | March 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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