Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

October 19, 2018 updated by: Philips Respironics
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
        • Sukhdev Grover and Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

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

Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Continuous dose
Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator.
Device: Continuous Dose
SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
EXPERIMENTAL: Pulse dose ('sleep mode')
Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator
Device: Pulse Dose (Sleep Mode)
SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Respironics

Investigators

  • Principal Investigator: Sukhdev Grover, MD, Medical Director, Sukhdev Grover and Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (ESTIMATE)

September 6, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRC-1216-SimGoSleep-SS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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