Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache (O214)
Primary Purpose
Chronic Headache
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
platinium IRC9LXO2AWQ
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Headache focused on measuring withdrawal therapy, oxygen therapy
Eligibility 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)
Sites / Locations
- Centre d'Urgence des Céphalées, hôpital LariboisièreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
platinium IRC9LXO2AWQ
Arm Description
Normobaric oxygen therapy with high flow concentrator to treat headaches attacks, 30 minutes of oxygene inhalation with mask, 9l/minute, no frequency limitation
Outcomes
Primary Outcome Measures
percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases
Secondary Outcome Measures
number of headache days per month
number of session of oxygen during the 6 months
number of rescue medication taking on the 6 months
Hospital Anxiety and Depression Scale
Headache Impact Test- 6
Patient Global Impressions of Change Scale
Migraine Disability Assessment Questionnaire Scale
Full Information
NCT ID
NCT02302027
First Posted
November 24, 2014
Last Updated
January 6, 2016
Sponsor
Association pour la Recherche au Centre d'Urgence des Céphalées
1. Study Identification
Unique Protocol Identification Number
NCT02302027
Brief Title
Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache
Acronym
O214
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Association pour la Recherche au Centre d'Urgence des Céphalées
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Headache
Keywords
withdrawal therapy, oxygen therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
platinium IRC9LXO2AWQ
Arm Type
Experimental
Arm Description
Normobaric oxygen therapy with high flow concentrator to treat headaches attacks, 30 minutes of oxygene inhalation with mask, 9l/minute, no frequency limitation
Intervention Type
Device
Intervention Name(s)
platinium IRC9LXO2AWQ
Intervention Description
high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm
Primary Outcome Measure Information:
Title
percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases
Time Frame
6th month
Secondary Outcome Measure Information:
Title
number of headache days per month
Time Frame
6th month
Title
number of session of oxygen during the 6 months
Time Frame
6th month
Title
number of rescue medication taking on the 6 months
Time Frame
6th month
Title
Hospital Anxiety and Depression Scale
Time Frame
1st month, 2d month and 3rd month
Title
Headache Impact Test- 6
Time Frame
1st, 2d and 3rd month
Title
Patient Global Impressions of Change Scale
Time Frame
1st, 2d, 3rd, 4th, 5th and 6th month
Title
Migraine Disability Assessment Questionnaire Scale
Time Frame
3rd and 6th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Roos, MD
Phone
00 33 1 49 95 89 53
Email
caroline.roos@aphp.fr
Facility Information:
Facility Name
Centre d'Urgence des Céphalées, hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Roos, MD
Phone
00 33 1 49 95 89 53
Email
caroline.roos@aphp.fr
First Name & Middle Initial & Last Name & Degree
Dominique Valade, MD
First Name & Middle Initial & Last Name & Degree
Caroline Roos, MD
First Name & Middle Initial & Last Name & Degree
Cecilia Burcin, MD
First Name & Middle Initial & Last Name & Degree
Jérôme Mawet, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
15689304
Citation
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.
Results Reference
result
PubMed Identifier
16305603
Citation
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.
Results Reference
result
PubMed Identifier
20298963
Citation
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.
Results Reference
result
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Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache
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