Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache (O214)

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

Study Overview

• Status: Unknown
• Conditions: Chronic Headache
• Intervention / Treatment: Device: platinium IRC9LXO2AWQ

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Centre d'Urgence des Céphalées, hôpital Lariboisière
    • Contact: Caroline Roos, MD; Phone Number: 00 33 1 49 95 89 53; Email: caroline.roos@aphp.fr
    • Sub-Investigator: Dominique Valade, MD
    • Principal Investigator: Caroline ROOS, MD
    • Sub-Investigator: Cecilia Burcin, MD
    • Sub-Investigator: Jérome MAWET, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Association pour la Recherche au Centre d'Urgence des Céphalées

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimate): November 26, 2014

Study Record Updates

• Last Update Posted (Estimate): January 7, 2016
• Last Update Submitted That Met QC Criteria: January 6, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: withdrawal therapy; oxygen therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache; Headache Disorders
• Other Study ID Numbers: ARCUC