KPAP vs EPR for Comfort

Официальное название

A Randomized Crossover Study of Subjective Comfort With At-Home Auto-Titrating Positive Airway Pressure (APAP): Kairos PAP (KPAP) Versus Expiratory Pressure Relief (EPR)

Обзор

The KPAP EPR Home is a randomized, crossover study in which subjective comfort will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR. Participants will be individuals with newly diagnosed OSA who have not previously tried any PAP treatment (PAP-naïve). Upon signing an informed consent, participants will be randomized to receiving either APAP + KPAP (delivered by a SleepRes device) or APAP + EPR (delivered by a ResMed device) for home use. Participants will be asked to use the devices (in the order of randomization) for 4 days each, with 3 days of washout in between. Participants will be blinded to the sequence order, even though they will receive machines that are not identical at each treatment. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. APAP will be set on the full pressure range (i.e., 5-20 cmH2O). After each period, each individual will be asked to rate their device preference according to a 10-point visual analog (VAS) scale (i.e., 1=extremely uncomfortable treatment; 10=extremely comfortable treatment). After usage, the devices will be returned to the office and device data will be downloaded.

Вмешательства

• Устройство APAP + KPAP
  A SleepRes device will deliver auto-adjusting positive airway pressure (APAP) + Kairos PAP at the maximum drop (1, 2, 3, 4, 5 cmH2O at background pressures of 6, 7, 8, 9, 10 cmH2O, respectively)
• Устройство APAP + EPR
  A ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3

Первичные конечные точки

• Subjective comfort [Срок оценки: This outcome will be evaluated after 4 days of treatment in each arm]

Вторичные конечные точки (3)

• P95 [Срок оценки: This outcome will be evaluated after 4 days of treatment in each arm]
• Residual AHI [Срок оценки: This outcome will be evaluated after 4 days of treatment in each arm]
• Adherence (in average h/night) [Срок оценки: This outcome will be evaluated after 4 days of treatment in each arm]

Критерии участия

Критерии включения

• BMI above 18 kg/m2, inclusive
• Recent formal diagnosis of OSA meeting all the following criteria: AHI > 10, Central apneas < 25% of events, PLM arousal index < 15, no prior/concomitant OSA therapy
• Subject is fluent in English and subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
• Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the study-related procedures.

Критерии исключения

• 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.).
• The presence of a psychiatric disorder, including attempted suicide within 1 year prior to screening, or current suicidal ideation.
• A serious illness or infection in the past 30 days.
• Excessive alcohol consumption (>21 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07530510 · Home 0003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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