N/A
Completed N=11
Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
Source: ClinicalTrials.gov NCT01679301 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Oxygen Saturation Values Obtained From Pulse Oximetry — 97.6; 95.8; 97; 96 percentage of oxygen saturation (SpO2)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxygen Saturation Values Obtained From Pulse Oximetry |
97.6; 95.8; 97; 96; 100; 97.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01679301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.