Sleep Disordered Breathing Clinical Trial
Official title:
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.
Primary Hypothesis and end-point:
The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those
participants no worse than when compared to the BiPAP S/T device with respect to:
- Apnea-Hypopnea Index (AHI)
Secondary Hypothesis and end-points:
The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those
participants no worse than the BiPAP S/T device, with respect to:
- Sleep Variables
- REM, NREM and Total Sleep Time (TST) Indices
- Apnea Hypopnea Index (AHI)
- Center Apnea Index(CAI)
- Obstructive Apnea Index (OAI)
- Mixed Apnea Index (MAI)
- Hypopnea Index (HI)
- Sleep Onset Latency (SOL)
- REM Onset Latency (ROL)
- Wake After Sleep Onset (WASO)
- Total Sleep Time (TST)
- Sleep Efficiency (SE %)
- Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (in minutes)
- Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST)
- Arousal Index [total, AH-related, PLM-related, 'spontaneous']
- Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study)
- AHI (REM, NREM and TST) using modified hypopnea rule.
- AHI (REM, NREM and TST) during epochs for which leak is determined to exist within
acceptable limits
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03927547 -
Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders
|
N/A | |
| Completed |
NCT03105297 -
To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep.
|
Phase 2 | |
| Completed |
NCT02894242 -
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
|
N/A | |
| Completed |
NCT02086448 -
Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)
|
N/A | |
| Completed |
NCT02188498 -
Electrocardiography Data Analysis in Sleep Disorders
|
||
| Completed |
NCT01120548 -
Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients
|
N/A | |
| Completed |
NCT01004471 -
An Exploratory Study of a Nasal Dilator Strip
|
Phase 2 | |
| Completed |
NCT02851628 -
The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort
|
N/A | |
| Completed |
NCT03748264 -
User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
|
N/A | |
| Active, not recruiting |
NCT02191085 -
Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing
|
N/A | |
| Completed |
NCT01467856 -
Sleep Disordered Breathing
|
N/A | |
| Completed |
NCT00909259 -
Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
|
Phase 1 | |
| Terminated |
NCT03353064 -
Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure
|
N/A | |
| Completed |
NCT03752580 -
An Investigation to Test a Prototype Nasal Mask in the Home Setting
|
N/A | |
| Completed |
NCT02987985 -
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy
|
Phase 3 | |
| Suspended |
NCT03964376 -
Nasal High Flow Therapy in Surgical Patients With Unrecognized Obstructive Sleep Apnea
|
N/A | |
| Completed |
NCT03725839 -
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
|
N/A | |
| Completed |
NCT02938208 -
An Investigation to Test a Prototype Full-face Mask in the Home Setting
|
N/A | |
| Completed |
NCT04086407 -
Apnea Hypopnea Index Severity Versus Head Position During Sleep
|
N/A | |
| Terminated |
NCT02296840 -
Post-operative Pain Control After Pediatric Adenotonsillectomy
|
Phase 4 |