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

• Sponsor: Fisher and Paykel Healthcare (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02368639
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Actual Duration (Months): 14
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive; Obesity Hypoventilation Syndrome	Device: Fisher & Paykel Healthcare PAP Device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Positive airway pressure (PAP) device 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.	Device: Fisher & Paykel Healthcare PAP Device; The device is a modified version of the Fisher & Paykel Icon continuous positive airway pressure (CPAP) device, which is a fully released product in New Zealand.

Outcome Measures

Primary Outcome Measures

1. Apnea hypopnea index (AHI) [8 hours]

   The number of apnea and hypopneas will be measured

2. Peripheral blood oxygen level (SpO2) [8 hours]

   Peripheral blood oxygen level will be measured

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fisher & Paykel Healthcare Sleep Laboratory	Auckland		New Zealand

Sponsors and Collaborators

• Fisher and Paykel Healthcare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fisher and Paykel Healthcare
• ClinicalTrials.gov Identifier: NCT02368639
• Other Study ID Numbers: CIA-156
• First Posted: Feb 23, 2015
• Last Update Posted: Aug 11, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypoventilation; Obesity Hypoventilation Syndrome

Study Results

No Results Posted as of Aug 11, 2017