This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

NOWOX Oxygen Therapy Monitoring Device

This study has been completed.
Information provided by (Responsible Party):
Air Liquide SA Identifier:
First received: November 28, 2008
Last updated: February 26, 2014
Last verified: February 2014
The purpose of this study is to evaluate the duration of oxygen use recorded by the NOWOX, under usual conditions of daily living, in patients with chronic obstructive respiratory disease requiring oxygen therapy.

Condition Intervention
Chronic Obstructive Pulmonary Disease Device: NOWOX

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of NOWOX: a Medical Device Developed to Record Duration of Oxygen Use and Respiration Rate in Patients Requiring Oxygen Therapy

Resource links provided by NLM:

Further study details as provided by Air Liquide SA:

Primary Outcome Measures:
  • Primary performance criterion is the overall estimated duration of oxygen use [ Time Frame: 6 hours ]

Secondary Outcome Measures:
  • secondary performance criterion: instantaneous respiration rate recorded by the NOWOX [ Time Frame: 6 hours ]
  • secondary performance criterion: patient's satisfaction questionnaire on the NOWOX [ Time Frame: 1 hour ]

Enrollment: 10
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxygen therapy
one experimental device assigned to each of the 10 patients including in the study for an experiemental session duration of 6 hours
Device: NOWOX
one experimental device assigned to each of the 10 patients including in the study for an experiemental session duration of 6 hours

Detailed Description:

Long Term Oxygen Therapy (LTOT) is one of the main non pharmacologic treatments for patients with severe lung disease. This continuous or sub-continuous oxygen supplementation is generally introduced at home in patients who have chronic cardio respiratory failure and severe resting hypoxemia to maintain sufficient blood oxygenation and therefore preserve vital organ function.

LTOT effectiveness has mainly been evaluated and documented in patients with COPD, which also accounts for most of its prescriptions. In these patients, LTOT has been shown to have a beneficial impact on haemodynamics, exercise capacity, lung mechanics and mental state. Its implementation was furthermore associated with reduced yearly hospitalisation days and increased survival Measuring adherence is an extremely important and under-evaluated component of oxygen therapy. NOWOX, medical device has been designed,developed and manufactured to measure adherence to LTOT and additionally to measure patient's respiration rate


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patient aged ≥ 18 years and ≤ 75 years,
  • Having a documented diagnosis of moderately severe to severe chronic obstructive respiratory disease
  • Hospitalised or out-patient requiring transient or long term oxygen therapy,
  • Able to be weaned from oxygen for several consecutive minutes (around 30 minutes, SpO2 at rest on room air should not drop < 85%),
  • Able to read
  • Willing and able to complete the requirements of this study including providing his/her signature for the written informed consent.

Exclusion Criteria:

  • Clinically unstable patient,
  • Any contraindication to perform a light cycling exercise, according to the 2003 ATS/ACCP guidelines
  • Tracheostomy,
  • Nasal obstruction or acute rhinitis occurring in the week prior to selection,
  • For female patient:
  • Pregnant,
  • Positive urinary pregnancy test
  • Lactating mother or lack of efficient contraception
  • Clinically significant or uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, autoimmune, neurological or psychiatric disorders which may interfere with the study procedures,
  • Known allergic reactions to medical material compounds used in the study
  • Drug abuse or psychic disorders
  • Legal status which prohibits informed consent,
  • Participation in any interventional clinical trial within 30 days prior to selection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00800072

Cochin University Hospital
Paris, France, 75014
Sponsors and Collaborators
Air Liquide SA
Principal Investigator: Anh-Tuan DINH-XUAN, Professor-MD Department of Physiology - Cochin University Hospital - FRANCE
  More Information

Responsible Party: Air Liquide SA Identifier: NCT00800072     History of Changes
Other Study ID Numbers: ALMED-07-MD-015
Study First Received: November 28, 2008
Last Updated: February 26, 2014

Keywords provided by Air Liquide SA:
to verify accurrancy of data collected by the NOWOX

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases processed this record on September 21, 2017