Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache (O214)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02302027|
Recruitment Status : Unknown
Verified January 2016 by Caroline ROOS, Association pour la Recherche au Centre d'Urgence des Céphalées.
Recruitment status was: Recruiting
First Posted : November 26, 2014
Last Update Posted : January 7, 2016
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
- verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator
- 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 or disease||Intervention/treatment||Phase|
|Chronic Headache||Device: platinium IRC9LXO2AWQ||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||October 2016|
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
- percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases [ Time Frame: 6th month ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302027
|Contact: Caroline Roos, MD||00 33 1 49 95 89 email@example.com|
|Centre d'Urgence des Céphalées, hôpital Lariboisière||Recruiting|
|Paris, France, 75010|
|Contact: Caroline Roos, MD 00 33 1 49 95 89 53 firstname.lastname@example.org|
|Sub-Investigator: Dominique Valade, MD|
|Principal Investigator: Caroline Roos, MD|
|Sub-Investigator: Cecilia Burcin, MD|
|Sub-Investigator: Jérôme Mawet, MD|