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PillowsPlus nasal cannula for sleep

Determining the effects of a PillowsPlus Nasal Cannula on oxygenation during ambulation and sleep

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13124681
Enrollment
27
Registered
2025-10-10
Start date
2025-06-05
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturnal oxygenation in patients on long-term oxygen therapy Respiratory

Interventions

We performed a three-night, two-sequence cross over study, adults on long-term oxygen therapy slept one night with a standard nasal cannula on a stationary continuous-flow concentrator (baseline), one

Sponsors

Alberta Innovates
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged over 18 years on chronic domiciliary oxygen therapy

Exclusion criteria

Exclusion criteria: 1. Requiring >6 L of O2 per minute at baseline 2. Previously established need for any nocturnal positive airway pressure therapy for conditions such as CPAP for obstructive sleep apnea (OSA), ASV for central sleep apnea, or BiPAP for obesity hypoventilation syndrome 3. Patients fully dependent on mechanical ventilation and/or those with facial injuries that preclude the use of a standard cannula or the PPNC will be excluded 4. Patients with an Apnea-Hypopnea Index (AHI) >15 will be excluded from further testing

Design outcomes

Primary

MeasureTime frame
Nocturnal average SpO2 by pulse oximetry, measured at baseline with a standard cannula + stationary concentrator compared to a PillowsPlus nasal cannula + a portable concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights. Designed and powered for non-inferiority.

Secondary

MeasureTime frame
1. Nocturnal average heart rate by pulse oximetry, measured at baseline with a standard cannula +stationary concentrator compared to a PillowsPlus nasal cannula +stationary concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights. 2. Frequency of oxygen desaturation events of 3% or greater by pulse oximetry, measured by blinded, manual scoring of oximetry data by a respirologist. Baseline recorded with standard cannula +stationary concentrator, compared to a PillowsPlus nasal cannula +stationary concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights. 3. Patient comfort data as measured with patient surveys at baseline with standard cannula +stationary concentrator, compared to a PillowsPlus nasal cannula +stationary concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights.

Countries

Canada

Contacts

Public ContactDaniel Vis
daniel.vis@ucalgary.ca+1 (0)403 956 2800

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026