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Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01679301
Recruitment Status : Completed
First Posted : September 6, 2012
Results First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

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.

Condition or disease Intervention/treatment Phase
Lung Disease Device: Pulse Dose (Sleep Mode) Device: Continuous Dose Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
Study Start Date : September 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679301


Locations
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United States, Pennsylvania
Sukhdev Grover and Associates
Monroeville, Pennsylvania, United States, 15146
Sponsors and Collaborators
Philips Respironics
Investigators
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Principal Investigator: Sukhdev Grover, MD Medical Director, Sukhdev Grover and Associates
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Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01679301    
Other Study ID Numbers: HRC-1216-SimGoSleep-SS
First Posted: September 6, 2012    Key Record Dates
Results First Posted: November 16, 2018
Last Update Posted: November 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philips Respironics:
oxygen
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases