Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

Lung Disease Clinical Trial

Official title:

Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679301
• Other study ID #: HRC-1216-SimGoSleep-SS
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2018
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases

Intervention

Device:
• Pulse Dose (Sleep Mode)
SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
• Continuous Dose
SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.

Locations

Country	Name	City	State
United States	Sukhdev Grover and Associates	Monroeville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Saturation Values Obtained From Pulse Oximetry	A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping	Day 1