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

Chronic Headache Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02302027
• Other study ID #: ARCUC
• Status: Recruiting
• Phase: N/A
• First received: November 24, 2014
• Last updated: January 6, 2016
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: January 2016
• Source: Association pour la Recherche au Centre d'Urgence des Céphalées
• Contact: Caroline Roos, MD
• Phone: 00 33 1 49 95 89 53
• Email: caroline.roos[@]aphp.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Headache
• Headache
• Headache Disorders

Intervention

Device:
• platinium IRC9LXO2AWQ
high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm

Locations

Country	Name	City	State
France	Centre d'Urgence des Céphalées, hôpital Lariboisière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Association pour la Recherche au Centre d'Urgence des Céphalées

Country where clinical trial is conducted

France, 

References & Publications (3)

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. Review. — View 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. Review. — View Citation

Lantéri-Minet M, Valade D, Géraud 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases		6th month	No
Secondary	number of headache days per month		6th month	No
Secondary	number of session of oxygen during the 6 months		6th month	No
Secondary	number of rescue medication taking on the 6 months		6th month	No
Secondary	Hospital Anxiety and Depression Scale		1st month, 2d month and 3rd month	No
Secondary	Headache Impact Test- 6		1st, 2d and 3rd month	No
Secondary	Patient Global Impressions of Change Scale		1st, 2d, 3rd, 4th, 5th and 6th month	No
Secondary	Migraine Disability Assessment Questionnaire Scale		3rd and 6th month	No