Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany

• Sponsor: Fisher and Paykel Healthcare (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02726048
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arm: 1
• Duration (Months): 15
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy

Condition or Disease	Intervention/Treatment	Phase
Obesity Hypoventilation Syndrome; Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease; Neuromuscular Disease	Device: Simplus/Eson	N/A

Detailed Description

Up to 40 NIV patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a Simplus (if they are existing full face users) or Eson (if they are existing nasal users) to use in-home for 2 weeks. This will consists of male and female participants who have been prescribed with NIV therapy for at least 3 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Full face/Nasal masks Simplus/Eson	Device: Simplus/Eson; Released product Simplus and Eson masks

Outcome Measures

Primary Outcome Measures

1. Objective Leak data [2 weeks]

   Obtained from the participant's device

Secondary Outcome Measures

1. Subjective measurement of Leak [2 weeks]

   Questionnaire

2. Subjective measurement of Comfort [2 weeks]

   Questionnaire

3. Subjective measurement of Ease of Use [2 weeks]

   Questionnaire

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Aged 18+

• Existing full face mask user or a nasal mask user

• Prescribed NIV therapy for at least 3 months

Exclusion Criteria:

• Inability to give informed consent

• Pregnant or think they may be pregnant

• Anatomical or physiological conditions making NIVtherapy inappropriate

• Patients who are in a coma or decreased level of consciousness

• Existing Simplus and Eson users

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité - Universitätsmedizin Berlin	Berlin		Germany	10117

Sponsors and Collaborators

• Fisher and Paykel Healthcare

Investigators

• Principal Investigator: Ingo Fietze, Professor, Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fisher and Paykel Healthcare
• ClinicalTrials.gov Identifier: NCT02726048
• Other Study ID Numbers: CIA178
• First Posted: Apr 1, 2016
• Last Update Posted: Aug 2, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive; Hypoventilation; Obesity Hypoventilation Syndrome; Neuromuscular Diseases

Study Results

No Results Posted as of Aug 2, 2018