Chronic Headache Clinical Trial
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
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
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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