Healthy Clinical Trial
Official title:
Study of the Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep: a Double-blind Randomized Controlled Trial
Sleep deprivation, which is a universal necessity, has serious physiological consequences. Sleep disorders are among the most common health problems, and yet they are often neglected. The osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes. Thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - Have sleep disorders (insomnia); - Volunteers between 18 and 30 years of age. Exclusion Criteria: - Attending the 3rd or 4th year of the Osteopathy Course; - Present fever (axillary or oral temperature higher than 37.5ยบ C); - Have a history of skull fracture; - Have a history of bleeding and intracranial hemorrhage; - Have a diagnosis of convulsion. |
Country | Name | City | State |
---|---|---|---|
Portugal | Escola Superior da Saúde do Porto | Porto |
Lead Sponsor | Collaborator |
---|---|
Escola Superior de Tecnologia da Saúde do Porto |
Portugal,
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Byun JI, Shin YY, Chung SE, Shin WC. Safety and Efficacy of Gamma-Aminobutyric Acid from Fermented Rice Germ in Patients with Insomnia Symptoms: A Randomized, Double-Blind Trial. J Clin Neurol. 2018 Jul;14(3):291-295. doi: 10.3988/jcn.2018.14.3.291. Epub 2018 Apr 27. — View Citation
Chigome, Audrey & Nhira, Sandra & Meyer, Johanna. (2018). An overview of insomnia and its management. SA Pharmaceutical Journal. 85. 32-38.
Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can alter sleep latency and sympathetic nerve activity in humans: a pilot study. J Altern Complement Med. 2005 Feb;11(1):103-8. doi: 10.1089/acm.2005.11.103. — View Citation
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Hasan F, Tu YK, Yang CM, James Gordon C, Wu D, Lee HC, Yuliana LT, Herawati L, Chen TJ, Chiu HY. Comparative efficacy of digital cognitive behavioral therapy for insomnia: A systematic review and network meta-analysis. Sleep Med Rev. 2022 Feb;61:101567. doi: 10.1016/j.smrv.2021.101567. Epub 2021 Nov 10. — View Citation
Henley CE, Ivins D, Mills M, Wen FK, Benjamin BA. Osteopathic manipulative treatment and its relationship to autonomic nervous system activity as demonstrated by heart rate variability: a repeated measures study. Osteopath Med Prim Care. 2008 Jun 5;2:7. doi: 10.1186/1750-4732-2-7. — View Citation
Hirshkowitz M. Normal human sleep: an overview. Med Clin North Am. 2004 May;88(3):551-65, vii. doi: 10.1016/j.mcna.2004.01.001. No abstract available. — View Citation
K Pavlova M, Latreille V. Sleep Disorders. Am J Med. 2019 Mar;132(3):292-299. doi: 10.1016/j.amjmed.2018.09.021. Epub 2018 Oct 4. — View Citation
McArdle N, Ward SV, Bucks RS, Maddison K, Smith A, Huang RC, Pennell CE, Hillman DR, Eastwood PR. The prevalence of common sleep disorders in young adults: a descriptive population-based study. Sleep. 2020 Oct 13;43(10):zsaa072. doi: 10.1093/sleep/zsaa072. — View Citation
Medalie L, Cifu AS. Management of Chronic Insomnia Disorder in Adults. JAMA. 2017 Feb 21;317(7):762-763. doi: 10.1001/jama.2016.19004. No abstract available. — View Citation
Nobles, T., Bach, A., & Boesler, D. (2016). Case report of osteopathic treatment of insomnia and traumatic anhidrosis. International Journal of Osteopathic Medicine, 21, 58-61. https://doi.org/10.1016/j.ijosm.2016.01.006
Perdereau-Noel M, Saliou P, Vic P. [Prevalence of teenage sleeping disorders]. Arch Pediatr. 2017 Apr;24(4):336-345. doi: 10.1016/j.arcped.2017.01.009. Epub 2017 Feb 24. French. — View Citation
van de Wouw E, Evenhuis HM, Echteld MA. Prevalence, associated factors and treatment of sleep problems in adults with intellectual disability: a systematic review. Res Dev Disabil. 2012 Jul-Aug;33(4):1310-32. doi: 10.1016/j.ridd.2012.03.003. Epub 2012 Mar 30. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, measures several different aspects of sleep. | 7 days post-intervention |
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