keePAP Device for Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Efficacy Study of the keePAP Device in Reducing the Number of Obstructive Breathing Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809418
• Other study ID #: keePAP-1.0
• Status: Completed
• Phase: N/A
• First received: March 10, 2013
• Last updated: April 2, 2018
• Start date: July 2013
• Est. completion date: October 2017

Study information

• Verified date: April 2018
• Source: Ninox Medical Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• keePAP

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Ninox Medical Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AHI/RDI and oxygen saturation during sleep	Efficacy of the keePAP system in reducing the number of obstructive breathing events during sleep as indexed by the AHI and measures of oxygen saturation during sleep.	one night
Secondary	Patient comfort	Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered.	one night