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OpenTrials
Completed

NCT Number: NCT01679301

Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

The SimplyGo Study is a single site, cross-over study which aims to enroll a maximum of 30 participants (to allow for 20 completed data sets) with a prescription for nocturnal oxygen, and meeting all eligibility criteria.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sukhdev Grover and Associates

Monroeville, Pennsylvania, 15146, United States

About this study

All participants will undergo a single night polysomnography testing in a sleep lab while they're oxygen saturation (SpO2) is monitored. The study has a cross-over design, in which participants will receive their oxygen prescription in two different modes at different times during the night. The assignment (sleep vs. continuous mode) to which participants will initiate the night will be randomized, and all participants will utilize each of the two modes during the study. The hypothesis of this study is that there will not be a significant difference in SpO2 for participants while they use the SimplyGo Portable Oxygen Concentrator, set in 'Sleep Mode', or pulsed oxygen flow, as compared to their SpO2 while on continuous flow oxygen during sleep during the course of the one night sleep study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and Females, ages 21-80
  • Current prescription for supplemental oxygen at night; Can be pulsed dose or continuous
  • Willing and able to provide informed consent

Exclusion criteria

  • Medically unstable participants per discretion of the principal investigator
  • Diagnosis of sleep apnea, per chart review, self report or rated high risk based on the Berlin Questionnaire
  • Participants unable or unwilling to spend one night in a sleep lab
  • Nocturnal oxygen requirements > 5 liters per minute
  • Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products
  • Employee or family member that is affiliated with Philips

Treatment and study plan

Pulse Dose (Sleep Mode)

Device

SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.

Continuous Dose

Device

SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.

Primary outcomes

  1. Oxygen Saturation Values Obtained From Pulse Oximetry

    Time frame: Day 1

    A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 6, 2012
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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