Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

NCT01679301 | Completed Results

• 1 other identifier: HRC-1216-SimGoSleep-SS
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Disease

Keywords

oxygen

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Continuous dose

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.

Device: Continuous Dose

Pulse dose ('sleep mode')

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

Device: Pulse Dose (Sleep Mode)

Interventions

Pulse Dose (Sleep Mode) DEVICE

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

Pulse dose ('sleep mode')

Continuous Dose DEVICE

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

Continuous dose

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (1)

Sukhdev Grover and Associates

Monroeville, Pennsylvania, 15146, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

• Title: Chuck Cain
• Organization: Philips Respironics

chuck.cain@philips.com

+1 724 7335835

Study Officials

• Sukhdev Grover, MD

  Medical Director, Sukhdev Grover and Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: September 6, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 16, 2018
• Results First Posted: November 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)