Phase IV Study of Bi-Level Positive Positive Airway Pressure (BiPAP)Compared to Nasal Continuous Positive Airway Pressure (CPAP) Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 6
- 主要终点
- Percentage of Group Compliance of the Auto Bilevel Group Compared to the CPAP Group
研究概览
简要总结
The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the continuous positive airway pressure (CPAP) group after 90 days of treatment during the investigation. Proportion will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each participant. The mean and standard deviation of these mean therapy hours will then be calculated for each arm of the investigation. Participants with compliance of at least four hours will be classified as "compliant" and those with less than four hours will be classified as "non-compliant". The null hypothesis will be rejected if the mean of the primary objective outcome for all participants in the BiPAP® Auto with Bi-Flex® therapy (auto Bilevel) arm is significantly greater than that for all participants in the CPAP therapy arm
详细描述
Initial Screening
It is preferred that participant's are recruited the morning after their failed clinical CPAP titration in the lab. Participants are able to be enrolled within ninety days following this failure if circumstances preclude approach and consent the morning after titration failure. Participants will be asked to wear the Actiwatch for approximately seven days prior to the clinical titration polysomnogram (PSG; and again for seven days prior to their final visit .) Actiwatch is worn on the participant's wrist to assess sleep continuity. Participants will be asked to press the "Marker button" on the Actiwatch when they get in bed each night to have a documented time mark when the device is downloaded. Participants will also be asked to fill in the sleep diary (provided by sleep clinic) during the seven days (14 days total; 7 at the beginning of the study and 7 days prior to the 90 Day visit) they use the Actiwatch.
Randomization/Therapy Initiated (Visit #1)
Participants will be randomized and scheduled for a BiPAP® Auto with Bi-Flex® titration or CPAP titration night in the lab. General therapy titration guidelines are documented in Appendix I & II (see Appendix I & II at end of document). Heart Rate Variability (HRV) will be assessed at both the diagnostic portion and titration portion of the research PSG. During the diagnostic portion of the research PSG, HRV needs to be assessed for ten minutes while the participant is awake. At the end of the titration portion of the research PSG, the HRV needs to be assessed for ten consecutive minutes while the participant is awake.
Enrolled participants will then complete a questionnaire to assess functional outcomes of sleep quality (FOSQ), Epworth Sleepiness Scale (ESS), Visual Analog Scale (VAS) for mask comfort and satisfaction with therapy, Psychomotor Vigilance Task (PVT), attitudes toward use measurement, and Fatigue Severity Scale (FSS; see Appendix III for description of measurements).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Participation in another interventional research study within the last 30 days
- •Major uncontrolled medical or psychiatric condition such as congestive heart failure, neuromuscular disease, renal failure etc.
- •Prior CPAP or Bi-Level PAP use (within last 2 years)
- •Chronic respiratory failure or insufficiency, moderate Chronic Obstructive Pulmonary Disease (COPD) (FEV1 < 60%), or any known condition of an elevation of arterial carbon dioxide levels while awake
- •Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
- •Presence of an untreated, diagnosable, non-OSA related sleep disorder (e.g. restless legs syndrome, insomnia, etc.)
- •Periodic Limb movement arousal index of 10 or greater.
- •Refusal to consider further interventions to standard CPAP to optimize positive pressure therapy (e.g. different mask than what was used in lab)
- •PAP therapy otherwise medically complicated or contraindicated such as those with a difficult to size or adjust interface (mask) resulting in facial pain, skin irritation or trauma, or excessive air leaks
- •Shift workers or people experiencing jet lag
- •Known history of alcohol and or drug abuse
- •Diagnosis of Complex Sleep Apnea, (appears to be classic obstructive or mixed sleep apnea, but exhibits disruptive central apneas and periodic breathing on CPAP) 11, 12 or persistent central apnea during diagnostic PSG.
- •Diagnosis of Attention Deficit Hyperactivity Disorder
- •Chronic Hypnotic use (nightly use for three months or less)
研究组 & 干预措施
Auto BiLevel Group
Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
干预措施: Auto BiLevel (Device)
CPAP Group
CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
干预措施: CPAP (Device)
结局指标
主要结局
Percentage of Group Compliance of the Auto Bilevel Group Compared to the CPAP Group
时间窗: 90 days
Percentage of Group Compliance was compared between AutoBiLevel Group and the CPAP group by measuring proportion of adherent users over the treatment period. Patients with compliance of at least four hours will be classified as "compliant" and those with less than four hours will be classified as "non-compliant". The % of compliant patients will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each subject.
Group Compliance of the Auto Bilevel Group Compared to the CPAP Group Measured by Average Nightly Use.
时间窗: 90 days
Compliance was compared between the AutoBiLevel Group and the CPAP group by measuring the average use per night over the study period.
次要结局
- Fatigue Severity Scale(Assessed at Baseline, Day 30 and Day 90)
- Functional Outcomes of Sleep Quality(Assessed at Baseline, Day 30 and Day 90)
- Epworth Sleepiness Scale(Assessed at Baseline, Day 30 and Day 90)