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

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ClinicalTrials.gov Identifier: NCT02302027
Recruitment Status : Unknown
Verified January 2016 by Caroline ROOS, Association pour la Recherche au Centre d'Urgence des Céphalées.
Recruitment status was:  Recruiting
First Posted : November 26, 2014
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Caroline ROOS, Association pour la Recherche au Centre d'Urgence des Céphalées

Tracking Information
First Submitted Date  ICMJE November 24, 2014
First Posted Date  ICMJE November 26, 2014
Last Update Posted Date January 7, 2016
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2014)
percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases [ Time Frame: 6th month ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
percentage of patients accepted the NOT treatment during withdrawal and consolidation phases [ Time Frame: 6th month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2014)
  • number of headache days per month [ Time Frame: 6th month ]
  • number of session of oxygen during the 6 months [ Time Frame: 6th month ]
  • number of rescue medication taking on the 6 months [ Time Frame: 6th month ]
  • Hospital Anxiety and Depression Scale [ Time Frame: 1st month, 2d month and 3rd month ]
  • Headache Impact Test- 6 [ Time Frame: 1st, 2d and 3rd month ]
  • Patient Global Impressions of Change Scale [ Time Frame: 1st, 2d, 3rd, 4th, 5th and 6th month ]
  • Migraine Disability Assessment Questionnaire Scale [ Time Frame: 3rd and 6th month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
  • number of headache days per month [ Time Frame: 6th month ]
  • number of session of oxygen during the 6 months [ Time Frame: 6th month ]
  • number of rescue medication taking on the 6 months [ Time Frame: 6th month ]
  • HAD scale [ Time Frame: 1st month, 2d month and 3rd month ]
  • HIT-6 scale [ Time Frame: 1st, 2d and 3rd month ]
  • PGIC scale [ Time Frame: 1st, 2d, 3rd, 4th, 5th and 6th month ]
  • MIDAS scale [ Time Frame: 3rd and 6th month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache
Official Title  ICMJE Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache With or Without Abuse of Painkillers
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

  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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Headache
Intervention  ICMJE Device: platinium IRC9LXO2AWQ
high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm
Study Arms  ICMJE 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
Intervention: Device: platinium IRC9LXO2AWQ
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 25, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02302027
Other Study ID Numbers  ICMJE ARCUC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Caroline ROOS, Association pour la Recherche au Centre d'Urgence des Céphalées
Study Sponsor  ICMJE Association pour la Recherche au Centre d'Urgence des Céphalées
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Association pour la Recherche au Centre d'Urgence des Céphalées
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP