Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Philips Respironics
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT01679301
First received: August 24, 2012
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

The SimplyGo Study is a single site, cross-over study which aims to enroll a maximum of 30 participants (to allow for 20 completers) with a prescription for nocturnal oxygen, and meeting all eligibility criteria. All participants will undergo a single night polysomnography testing in a sleep lab while they're 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 oxygen saturation (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.


Condition
People Requiring Supplemental Oxygen at Night

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

Resource links provided by NLM:


Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • Oxygen saturation values obtained from pulse oximetry [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping


Estimated Enrollment: 20
Study Start Date: September 2012
Groups/Cohorts
Continuous dose oxygen first part of night
Users will be randomized to either receive oxygen via continuous dose or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night.
Pulse dose ('sleep mode') first part of night
Users will be randomized to either receive oxygen via continuous dose or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants will be recruited from the Principal Investigator's clinic, as well as the Philips Respironics Home Healthcare Research Registry. This study is designed to allow both continuous and pulsed dose nocturnal oxygen users to participate.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679301

Contacts
Contact: Sukhdev Grover, MD 412-856-5778 ssgrovermd@yahoo.com
Contact: Melanie Cady 412-856-0700 melaniecady@gmail.com

Locations
United States, Pennsylvania
Sukhdev Grover and Associates Recruiting
Monroeville, Pennsylvania, United States, 15146
Contact: Sukhdev Grover, MD    412-856-5778    ssgrovermd@yahoo.com   
Contact: Melanie Cady    412-856-0700    melaniecady@gmail.com   
Principal Investigator: Sukhdev Grover, MD         
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Sukhdev Grover, MD Medical Director, Sukhdev Grover and Associates
  More Information

No publications provided

Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01679301     History of Changes
Other Study ID Numbers: HRC-1216-SimGoSleep-SS
Study First Received: August 24, 2012
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Philips Respironics:
oxygen

ClinicalTrials.gov processed this record on September 18, 2014