keePAP Device for Treatment of Obstructive Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-10-31

Brief Summary

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The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the Apnea Hyperpnoea Index (AHI) or Respiratory Disturbance Index (RDI) and measures of oxygen saturation during sleep.

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Detailed Description

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Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. Associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems.

The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the AHI/RDI and measures of oxygen saturation during sleep.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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keePAP

Group Type EXPERIMENTAL

keePAP

Intervention Type DEVICE

Interventions

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keePAP

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age over between 18 and 80 years old;
* AHI/RDI \> 5

Exclusion Criteria

* Uncontrolled or serious illness (angina/myocardial infarction, cancer, stroke, dementia, congestive heart failure),
* Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment;
* History of severe nasal allergies or sinusitis or difficulty breathing through the nose;
* Persistent blockage of one or both nostrils;
* Any previous operation or trauma to the nose;
* Any nasal, facial or head abnormalities that would not allow adequate placement of the device.
* Previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure.
* Female subjects of childbearing age were excluded if they were pregnant or intending to become pregnant.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No