Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

Philips

Status: Completed

Conditions: Lung Disease

Treatments: Device: Continuous Dose; Device: Pulse Dose (Sleep Mode)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01679301

HRC-1216-SimGoSleep-SS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Continuous dose

Active Comparator group

Description:

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.

Treatment:

Device: Continuous Dose

Pulse dose ('sleep mode')

Experimental group

Description:

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

Treatment:

Device: Pulse Dose (Sleep Mode)