Primary Headache Disorder Clinical Trial
Official title:
Efficacy of Oxygen Therapy in Primary Headache Disorder
NCT number | NCT05511155 |
Other study ID # | 64-SBKAEK |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2022 |
Est. completion date | September 30, 2022 |
Verified date | September 2022 |
Source | Aksaray University Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Headache is one of the common causes of emergency department admissions and constitutes approximately 2%. Although the exact mechanism is not clear, It is known that high-flow oxygen therapy is effective in headache treatment. There are limited studies related to the use of oxygen therapy in headaches and its derivatives in the literature. In this study, the investigators aimed to compare the high and medium flow oxygen therapies with placebo in primary headache disorders.
Status | Completed |
Enrollment | 132 |
Est. completion date | September 30, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - age 18-55 years - frequent attacks of primary headache disorders according to International Headache Society (IHS) criteria Exclusion Criteria: - secondary headache disorders - oxygen-dependent chronic illnesses such as chronic obstructive pulmonary disease - a history of cerebrovascular disease - pregnancy - active smokers or living with a smoker. |
Country | Name | City | State |
---|---|---|---|
Turkey | Aksaray University Aksaray Training and Research Hospital | Aksaray |
Lead Sponsor | Collaborator |
---|---|
Aksaray University Training and Research Hospital |
Turkey,
Friedman BW, Grosberg BM. Diagnosis and management of the primary headache disorders in the emergency department setting. Emerg Med Clin North Am. 2009 Feb;27(1):71-87, viii. doi: 10.1016/j.emc.2008.09.005. Review. — View Citation
Mo H, Chung SJ, Rozen TD, Cho SJ. Oxygen Therapy in Cluster Headache, Migraine, and Other Headache Disorders. J Clin Neurol. 2022 May;18(3):271-279. doi: 10.3988/jcn.2022.18.3.271. Review. — View Citation
Petersen AS, Barloese MC, Lund NL, Jensen RH. Oxygen therapy for cluster headache. A mask comparison trial. A single-blinded, placebo-controlled, crossover study. Cephalalgia. 2017 Mar;37(3):214-224. doi: 10.1177/0333102416637817. Epub 2016 Jul 11. — View Citation
Roberto G, Raschi E, Piccinni C, Conti V, Vignatelli L, D'Alessandro R, De Ponti F, Poluzzi E. Adverse cardiovascular events associated with triptans and ergotamines for treatment of migraine: systematic review of observational studies. Cephalalgia. 2015 Feb;35(2):118-31. doi: 10.1177/0333102414550416. Epub 2014 Sep 22. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | visual analog scale score | primary endpoint is the relative reduction in visual analog scale (a psychometric response scale) score in the placebo versus oxygen group to determine whether there was a difference between the high-flow and mid-flow therapies. visual analog scale scaled from 0-100 points with 0 meaning "no pain" and 100 points meaning "worst possible pain". | 0-60 minutes | |
Secondary | rescue analgesia | rescue analgesia (yes/no) | 30 th minutes | |
Secondary | length of stay | length of stay in the emergency department (time in minutes) | 0-300 minutes | |
Secondary | duration of a pain | duration of a pain attack (time in minutes) | 0-300 minutes | |
Secondary | readmission | readmission to the emergency department within 7 days (yes/no) | 0-7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00449787 -
Comparing Naproxen to Sumatriptan for Emergency Headache Patients
|
Phase 4 | |
Recruiting |
NCT04080258 -
Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.
|
N/A | |
Active, not recruiting |
NCT04178252 -
Effectiveness of Eye Mask and Noise Reduction Headset in Primary Headache
|
N/A | |
Not yet recruiting |
NCT05057533 -
Primary Headaches and Irritable Bowel Syndrome.
|
||
Enrolling by invitation |
NCT05760625 -
Gender Differences and Features of the Clinical Course of Primary Headaches
|
||
Withdrawn |
NCT05337930 -
Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine
|
N/A | |
Active, not recruiting |
NCT05023460 -
Treatment of Chronic Cluster Headache With TENS and ONS
|
N/A | |
Recruiting |
NCT03499392 -
Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.
|
N/A |