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Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache (O214)

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2016 by Caroline ROOS, Association pour la Recherche au Centre d'Urgence des Céphalées
Sponsor:
Information provided by (Responsible Party):
Caroline ROOS, Association pour la Recherche au Centre d'Urgence des Céphalées
ClinicalTrials.gov Identifier:
NCT02302027
First received: November 24, 2014
Last updated: January 6, 2016
Last verified: January 2016
  Purpose

Chronic headache is most often associated with drug abuse and medication overuse headache (MOH) is the main complication of migraine disease results in chronic daily headache. The first phase of treatment consists of drug withdrawal .

The second phase of treatment (called consolidation) is to maintain the balance: treating headaches and reducing / stopping the drug use.

The aim of this study is

  1. verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator
  2. use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through withdrawal period.

It is a feasibility pilot study in chronic headache with or without medication-overuse. All patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and used to be called "traditional management". The subsequent attacks will be treated with NOT from a high-flow concentrator

Primary endpoint. Feasibility study of treatment with NOT evaluated by the percentage of patients who accepted NOT during the withdrawal phase then to treat attacks.

Secondary endpoints. Efficacy will be assessed by the percentage of patients having no chronic headaches two months after the start of withdrawal (less than 15 days of headache per month) and no longer in drug abuse (less than 10 days per month with drug intake).

Visits V1 (first visit) Inclusion V2 at one month V3 at 3 months V4 (last vist) at 6 months

Effective : 30 patients


Condition Intervention
Chronic Headache Device: platinium IRC9LXO2AWQ

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache With or Without Abuse of Painkillers

Resource links provided by NLM:


Further study details as provided by Caroline ROOS, Association pour la Recherche au Centre d'Urgence des Céphalées:

Primary Outcome Measures:
  • percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases [ Time Frame: 6th month ]

Secondary Outcome Measures:
  • number of headache days per month [ Time Frame: 6th month ]
  • number of session of oxygen during the 6 months [ Time Frame: 6th month ]
  • number of rescue medication taking on the 6 months [ Time Frame: 6th month ]
  • Hospital Anxiety and Depression Scale [ Time Frame: 1st month, 2d month and 3rd month ]
  • Headache Impact Test- 6 [ Time Frame: 1st, 2d and 3rd month ]
  • Patient Global Impressions of Change Scale [ Time Frame: 1st, 2d, 3rd, 4th, 5th and 6th month ]
  • Migraine Disability Assessment Questionnaire Scale [ Time Frame: 3rd and 6th month ]

Estimated Enrollment: 30
Study Start Date: December 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: platinium IRC9LXO2AWQ
Normobaric oxygen therapy with high flow concentrator to treat headaches attacks, 30 minutes of oxygene inhalation with mask, 9l/minute, no frequency limitation
Device: platinium IRC9LXO2AWQ
high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Migrainous according to the criteria of the International Headache Society
  • Medication-overuse headaches according of the International Headache Society
  • No prophylaxis treatment or same prophylaxis treatment from more than one month
  • Signed informed consent

Exclusion Criteria:

  • Pregnancy
  • One or more failed withdrawal treatment
  • analgesic treatment for another reason than headache
  • Contraindication of normobaric oxygen therapy
  • Contraindication of ketoprofen (rescue therapy)
  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 ClinicalTrials.gov identifier: NCT02302027

Contacts
Contact: Caroline Roos, MD 00 33 1 49 95 89 53 caroline.roos@aphp.fr

Locations
France
Centre d'Urgence des Céphalées, hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Caroline Roos, MD    00 33 1 49 95 89 53    caroline.roos@aphp.fr   
Sub-Investigator: Dominique Valade, MD         
Principal Investigator: Caroline Roos, MD         
Sub-Investigator: Cecilia Burcin, MD         
Sub-Investigator: Jérôme Mawet, MD         
Sponsors and Collaborators
Association pour la Recherche au Centre d'Urgence des Céphalées
  More Information

Publications:
Responsible Party: Caroline ROOS, Medical Doctor, Association pour la Recherche au Centre d'Urgence des Céphalées
ClinicalTrials.gov Identifier: NCT02302027     History of Changes
Other Study ID Numbers: ARCUC
Study First Received: November 24, 2014
Last Updated: January 6, 2016

Keywords provided by Caroline ROOS, Association pour la Recherche au Centre d'Urgence des Céphalées:
withdrawal therapy
oxygen therapy

Additional relevant MeSH terms:
Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 19, 2017