Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache
NCT ID: NCT02302027
Last Updated: 2016-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2014-12-31
2016-10-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
platinium IRC9LXO2AWQ
high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 \* 67 \* 36 cm
Interventions
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platinium IRC9LXO2AWQ
high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 \* 67 \* 36 cm
Eligibility Criteria
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Inclusion Criteria
* 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
* One or more failed withdrawal treatment
* analgesic treatment for another reason than headache
* Contraindication of normobaric oxygen therapy
* Contraindication of ketoprofen (rescue therapy)
18 Years
ALL
No
Sponsors
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Association pour la Recherche au Centre d'Urgence des Céphalées
OTHER
Responsible Party
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Caroline ROOS
Medical Doctor
Locations
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Centre d'Urgence des Céphalées, hôpital Lariboisière
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Kavuk I, Katsarava Z, Selekler M, Sayar K, Agelink MW, Limmroth V, Diener HC. Clinical features and therapy of medication overuse headache. Eur J Med Res. 2004 Dec 22;9(12):565-9.
Lanteri-Minet M, Valade D, Geraud G, Chautard MH, Lucas C. Migraine and probable migraine--results of FRAMIG 3, a French nationwide survey carried out according to the 2004 IHS classification. Cephalalgia. 2005 Dec;25(12):1146-58. doi: 10.1111/j.1468-2982.2005.00977.x.
Evers S, Marziniak M. Clinical features, pathophysiology, and treatment of medication-overuse headache. Lancet Neurol. 2010 Apr;9(4):391-401. doi: 10.1016/S1474-4422(10)70008-9.
Other Identifiers
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ARCUC
Identifier Type: -
Identifier Source: org_study_id
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