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BiPAPRescuePhase IV Study of Bi-Level Positive Positive Airway Pressure (BiPAP)Compared to Nasal Continuous Positive Airway Pressure (CPAP) Therapy

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

CPAP

+ Auto BiLevel

Dispositivo
Quiénes están siendo reclutados

Apnea+3

+ Enfermedades del sistema nervioso

+ Trastornos de la respiración

De 21 a 75 años
+14 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio Diagnóstico

Intervencional
Inicio del estudio: agosto de 2007
Ver detalles del protocolo

Resumen

Patrocinador PrincipalPhilips Respironics
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de agosto de 2007

Fecha en la que se inscribió al primer participante.

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). Participants will be set up with their respective machines after titration or within ten days (10 +/- 2) days of titration and will take these devices home for the next three months. Thus, total participation in the trial will be on average 3-4 months. All positive airway pressure machines will include a programmed SmartCard to monitor objectively compliance. Participants randomized to standard CPAP therapy will receive a SmartCard programmed to provide CPAP at their prescribed pressure. Both the participant and the sleep health staff administering the questionnaires and psychomotor vigilance task, will be blinded to the therapy the SmartCard is programmed to provide. Participants randomized to novel therapy will receive a SmartCard programmed to provide BiPAP® Auto with Bi-Flex®. The SmartCard programming will be done by an unblinded study staff member. The settings for the novel therapy will be: * Min Expiratory Positive Airway Pressure (EPAP) = 4 cmH2O for prescribed CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O) * Max Inspiratory Positive Airway Pressure (IPAP) = 25 cm H2O * Min Pressure Support (PS) = 2 cm H2O (cannot be adjusted) * MaxPS = 8 cm H2O * Bi-Flex setting of 3 The SmartCard is inserted into the device to provide the programmed therapy. Both the participant and CPAP therapist will be blinded to the therapy the SmartCard is programmed to provide. The other supplies necessary to use the therapy at home will also be provided to the participant (i.e. mask, tubing, humidifier, etc.). The CPAP therapist will also provide the training necessary to use the device at home and provide a number to call in case the participant encounters any difficulty using the device at home. Standardized Counseling to Optimize Adherence to Therapy Counseling to optimize adherence to CPAP therapy will consist of: 1. The clinician will discuss complaints regarding CPAP therapy to identify potential contributors to poor adherence to therapy. The standardized counseling to optimize adherence includes the following measures to address patient complaints and concerns: Interface * Assure current mask is properly applied and headgear is properly adjusted. * Persistent mask leaks or mask discomfort, skin trauma, or skin irritation will be addressed first by verifying mask and headgear adjustment and mask sizing. An alternate mask can be used if the problems cannot be addressed by fit or adjustment interventions. * If mouth leaks are the primary concern and a nasal mask is being used, then a nasal/oral mask will be considered or a chin strap will be offered in combination with nasal mask use. Therapy Side Effects * All patients will have initially been placed on a CPAP device with heated humidification. For continued oro-pharyngeal dryness, nasal dryness, nasal congestion, or rhinitis, humidification will be increased. Saline nasal sprays, steroids, or decongestants can be prescribed, if needed. * Dyspnea on CPAP or claustrophobia will be addressed with counseling as needed. * Note: Reducing the prescribed pressure to improve adherence will not be considered at this time. 2. A standardized description of obstructive sleep apnea (OSA) and its risks will be reviewed with the participant, as well as the American Academy of Sleep Medicine Fact Sheet Drowsy Driving (see Appendix III). 3. A standardized description of the evidence regarding the benefits of positive pressure therapy to treat OSA will be reviewed with the participant. Participants will be instructed to use the device as much as possible while they are sleeping and to also make sure they allow an adequate opportunity to sleep each night.

Título OficialPhase IV Study of Bi-Level Positive Positive Airway Pressure (BiPAP)Compared to Nasal Continuous Positive Airway Pressure (CPAP) Therapy
NCT02522442
Patrocinador PrincipalPhilips Respironics
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 51 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio Diagnóstico

Los estudios diagnósticos se centran en mejorar como se detecta o confirma una enfermedad. Prueban nuevas herramientas o técnicas que podrían ofrecer diagnósticos más rápidos o precisos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 21 a 75 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

ApneaEnfermedades del sistema nerviosoTrastornos de la respiraciónEnfermedades del Tracto RespiratorioSíndromes de Apnea del SueñoTrastornos del sueño-vigilia

Criterios

14 criterios de exclusión impiden participar
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

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Comparador Activo
CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea

Grupo II

Experimental
Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 3 ubicaciones

Suspendido

Brigham and Women's Hospital

Boston, United StatesAbrir Brigham and Women's Hospital en Google Maps
Suspendido

Mayo Clinics

Rochester, United States
Suspendido

Clayton Sleep Institute

St Louis, United States
Completado3 Centros de Estudio