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

Study Overview
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Brief Summary
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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

Official Title
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Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache With or Without Abuse of Painkillers

Conditions
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Chronic Headache

Intervention / Treatment
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* Device: platinium IRC9LXO2AWQ


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platinium IRC9LXO2AWQ<br>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<br>* high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases |  | 6th month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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withdrawal therapy, oxygen therapy