Completed

Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Continuous Dose

+ Pulse Dose (Sleep Mode)

Device
Who is being recruted

Respiratory Tract Diseases

+ Lung Diseases

From 21 to 80 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorPhilips Respironics
Last updated: November 16, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01679301
Principal SponsorPhilips Respironics
Last updated: November 16, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

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

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Respiratory Tract DiseasesLung Diseases

Criteria

3 inclusion criteria required to participate
Current prescription for supplemental oxygen at night; Can be pulsed dose or continuous
Males and Females, ages 21-80
Willing and able to provide informed consent
6 exclusion criteria prevent from participating
Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products
Diagnosis of sleep apnea, per chart review, self report or rated high risk based on the Berlin Questionnaire
Employee or family member that is affiliated with Philips
Medically unstable participants per discretion of the principal investigator
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Group II

Experimental
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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Sukhdev Grover and Associates

Monroeville, United StatesOpen Sukhdev Grover and Associates in Google Maps
CompletedOne Study Center