A Prospective, Randomized, Crossover Study of Therapy Adherence With Kairos Positive Airway Pressure (KPAP) Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Usage
研究概览
简要总结
A device able to provide less positive airway pressure (PAP) for the entire duration of inspiration and roughly half the duration of expiration, designated KPAP, is being developed by SleepRes for the treatment of obstructive sleep apnea (OSA). In prior studies, the administration of higher inspiratory than expiratory PAP did not substantially increase treatment efficacy or adherence to continuous PAP (CPAP), which remains low. In our recent investigation, we demonstrated that the addition of a resistor to the CPAP circuit to reduce inspiratory PAP increased subjective comfort. In another study, we showed that KPAP improved subjective comfort during wakefulness vs. fixed CPAP, while maintaining treatment efficacy. The present study, KPAP Adherence 1, is a randomized, crossover study designed to examine whether KPAP can improve adherence over APAP as an at home treatment for OSA.
详细描述
The KPAP Adherence 1 is a randomized, crossover study in which the adherence to therapy will be compared between KPAP and standard APAP. Participants will be chosen from a pool of patients who are PAP-naïve and who have received either a PSG (in-lab polysomnogram), split-night study (in-lab PSG and pressure titration) or home sleep study (HST) within the previous 3 months.
Upon signing an informed consent, participants will be randomly assigned to start on either the KPAP (supplied by a SleepRes device) or the APAP (supplied by a ResMed device) arm when they arrive at the office. Each participant will then be given their new equipment and will be trained in proper use of the device assigned for the first treatment arm. The device will be used at home, nightly, for 4 weeks. Afterward, they will return to the office for their second visit. They will then be given the other device-along with the appropriate explanation on how to use it-that they will use on their second treatment arm. Subsequently, they will undergo a washout period of 1 week where no therapy will be used. Following the washout period, they will initiate another 4-week usage with the second therapy device. At the end of the second 4-week period, participants will return to the office for their third visit.
In both the APAP and KPAP arms, participants will have their therapy set to 5-20 cmH2O for one week. The pressure range will then be narrowed to ± 2 cmH2O around their 95% pressure level as assessed during the first week. This same pressure range will be used during the second arm for each patient.
During the KPAP arm, participants will be set to a double Comfort Setting drop according to the following scheme. This drop schedule will be implemented while the KPAP device is operating with automatic pressure adjustment.
Pset Drop 1 Drop 2 5.0 - 5.9 0 0 6.0 - 6.9 1 0 7.0 - 7.9 2 0 8.0 - 8.9 2 1 9.0 - 9.9 2 2 10.0 - 20.0 2 3
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will not be told what therapy they will be using in either arm, and since they are naive to PAP therapy, they would be more blinded than adherent patients.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI > 10 on a previous PSG or HST (hypopneas requiring 4% desaturation).
- •Central apneas < 25% of events
- •PLM (Periodic Limb Movements) arousal index < 15
排除标准
- •A female of child-bearing potential that is pregnant or intends to become pregnant.
- •Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, etc., or at the discretion of the site Principal Investigator (PI).
- •Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, anticonvulsants, etc.
- •The presence of any other sleep disorder (insomnia, periodic limb movement disorder, etc).
- •Prior therapy or treatment for OSA.
- •Chronic oxygen therapy.
- •Excessive alcohol consumption (>14 drinks/week).
- •The use of any illegal drug(s).
- •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.
研究组 & 干预措施
4-weeks breathing on APAP
Patients will breathe on APAP for 4 weeks simulating normal therapy. Usage, leak, P95/P90 and AHI will be recorded and averaged over the duration.
干预措施: APAP (Device)
4-weeks breathing on KPAP
Patients will breathe on TheraPAP for 4 weeks, which is the therapy under evaluation. Usage, leak, P95/P90 and AHI will also be recorded and averaged over the duration.
干预措施: KPAP (Device)
结局指标
主要结局
Usage
时间窗: Averaged over every night for each 6-week arm
Number of hours for which therapy is used per night
次要结局
- ESS Questionnaire(Filled out twice, once after completion of each 6-week arm (at week 6 and at week 13))
- FOSQ-10 Questionnaire(Filled out twice, once after completion of each 6-week arm (at week 6 and at week 13))
- Excess Leak or Leak(Averaged over every night for each 6-week arm)
- P95/P90(Averaged over every night for each 6-week arm)
- AHI(Averaged over every night for each 6-week arm)