Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing

Fisher & Paykel Healthcare

Status: Terminated

Conditions: Sleep Apnea, Obstructive; Obesity Hypoventilation Syndrome

Treatments: Device: Fisher & Paykel Healthcare PAP Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02368639

CIA-156

Details and patient eligibility

About

This study will use a modified version of a positive airway pressure device to supply air to the participant, while undergoing supervised polysomnography. Positive airway pressures are typically applied to many patients with hypoventilation, in this study these pressures will be titrated by a qualified sleep technician. During the night these pressures will be altered to optimise comfort.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18+
• Patients diagnosed with obesity hypoventilation syndrome (OHS) and/or obstructive sleep apnea (OSA) by a practicing sleep or respiratory physician, requiring positive airway pressure (PAP) therapy

Exclusion criteria

• Recent cardiac or respiratory arrest
• Gastro intestinal bleeding, ileus or recent gastrointestinal surgery
• Coma, decreased level of consciousness or agitation
• Anatomical or subjective difficulty with airway access e.g. facial surgery, trauma, vomiting upper airway obstruction
• Cerebrospinal fluid leak, abnormalities of the cribiform plate or prior history of head trauma.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Positive airway pressure (PAP) device

Experimental group

Description:

Fisher \& Paykel Healthcare PAP Device. Participants will sleep overnight using themodified positive airway pressure device. Their pressures will be titrated by a qualified sleep technician, they will then be optimised during the night.

Treatment:

Device: Fisher & Paykel Healthcare PAP Device