A Study to Evaluate the Use of a Smartphone App for Stroke Patients with Obstructive Sleep Apnea

Overview

Información sobre este estudio

The purpose of this study is to evaluate the use of a smartphone app for stroke patients with obstructive sleep apnea in order to better use their positive airway pressure (PAP) therapy.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria - Aim 1:

  • Clinical diagnostic testing via laboratory or home-based sleep study indicates diagnosis of obstructive sleep apnea.
  • Currently use an appropriate Apple (iOS9 or higher) or Android (4.2 or higher) smartphone device.
  • Able to read and understand English.
  • Prescribed continuous or auto-titrated PAP treatment for obstructive sleep apnea.
  • Stroke diagnosis with stroke event occurring within 36 months.

Inclusion Criteria - Aim 2: 

  • Clinical diagnostic testing via laboratory or home-based sleep study indicates diagnosis of obstructive sleep apnea.
  • Currently use an appropriate Apple (iOS9 or higher) or Android (4.2 or higher) smartphone device.
  • Able to read and understand English.
  • Prescribed continuous or auto-titrated PAP treatment for obstructive sleep apnea.
  • Stroke diagnosis with stroke event occurring no more than 10 years prior to referral to Center for Sleep Medicine.
  • Functional and cognitive  ability to manage smartphone application and PAP device with minimal to no assistance.
  • Agree to using a smartphone application and wearable wrist sensor.

Inclusion Criteria - Aim 3:

  • Health care provider (MD, APRN, PA, RN) providing care to patients with OSA and history of stroke.
  • Sleep Medicine.
  • Primary Care.

Exclusion Criteria: 

  • Communication or cognitive impairments that limit ability to read and/or follow directions.
  • Currently participating in other lifestyle programs (e.g., active, formal weight loss program or research study; smoking cessation program, etc.).
  • Has lost 10lb or 4.5kg or more over the past 4 weeks.
  • Other acute or severe health, cognitive, or psychological conditions that prevent participation.
  • Self-report of pregnant, lactating, or trying to become pregnant.
  • Decide to use different PAP device than ResMED Airsense 10.
  • Prescribed high-dose benzodiazepines (equivalent to > 1 mg lorazapam/night).
  • Daily opioid medication use at night.
  • Unwilling to discontinue use of any current wearable sensor for the duration of the trial.
  • Previous documented history of treatment/referral for claustrophobia.
  • Previous PAP use.
  • Other conditions determined by a sleep medicine team member that may interfere with full participation in the trial.
  • Planning to travel for more than seven consecutive nights during the trial.
  • Currently engaging in shiftwork defined as night shift or rotating day and night shifts.
  • Unwilling to have an in-person follow-up appointment at the Center for Sleep Medicine in Rochester.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Lori Rhudy, R.N.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Jack Jagielski

(507) 266-6627

Jagielski.Jack@mayo.edu

More information

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CLS-20486394

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