Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-09-30
2024-12-31
Brief Summary
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Detailed Description
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Both compression of 4th ventricle and diaphragmatic techniques have been proven to help lower the tone of the sympathetic nervous system, restoring a normal respiratory mechanism.
It is anticipated that the combination of 4th ventricle technique and diaphragmatic breathing may result in a significant reduction in insomnia symptoms, providing study participants with a notable improvement in the quality of sleep and, therefore, in their general well-being.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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4th ventricle compression technique
Experimental:
4th ventricle compression technique
4th ventricle compression technique
For the CV4 the mediator's hands assume a specific position: one on top of the other, with the tips of the thumbs joined together in a "V" shape, positioned approximately on the process spinous between the patient's second and third cervical vertebrae, pointing downwards.
Diaphragmatic breathing technique
Experimental:
Diaphragmatic breathing technique
Diaphragmatic breathing technique
For the diaphragmatic breathing the participant will place one hand on their chest and the other over their abdomen. Both of their hands will be overlapped by the mediator's, so it is easier to feel the correct breathing movements to be performed.
Sham Tecnhique
Placebo Comparator:
Sham Technique
Sham Technique
The participant is instructed to lie down in the supine position while the mediator assumes a position at the head of the table and places their hands on the participant's shoulders. This technique is performed for 5 minutes.
Interventions
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4th ventricle compression technique
For the CV4 the mediator's hands assume a specific position: one on top of the other, with the tips of the thumbs joined together in a "V" shape, positioned approximately on the process spinous between the patient's second and third cervical vertebrae, pointing downwards.
Sham Technique
The participant is instructed to lie down in the supine position while the mediator assumes a position at the head of the table and places their hands on the participant's shoulders. This technique is performed for 5 minutes.
Diaphragmatic breathing technique
For the diaphragmatic breathing the participant will place one hand on their chest and the other over their abdomen. Both of their hands will be overlapped by the mediator's, so it is easier to feel the correct breathing movements to be performed.
Eligibility Criteria
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Inclusion Criteria
* insomnia presence
* willingness to complete a full study period
* understanding and acceptance of the study procedures
* willingness to refrain from other intervention during the study period
* availability to keep a diary (sleep and mood throughout the day)
Exclusion Criteria
* hypertension
* fractured the base of the skull
* pregnancy
* active insomnia treatment
* participation in other simultaneous studies
* regular use of sleep medication
* have participated in complementary therapies for insomnia recently
18 Years
28 Years
ALL
No
Sponsors
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Escola Superior de Tecnologia da Saúde do Porto
OTHER
Responsible Party
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Natália Maria Oliveira Campelo
Prinicipal Investigator
Principal Investigators
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Natália MO Campelo, PhD
Role: PRINCIPAL_INVESTIGATOR
Escola Superior da Saúde do Porto
Central Contacts
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References
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Bordoni B, Escher AR Jr. Osteopathic Principles: The Inspiration of Every Science Is Its Change. Cureus. 2021 Jan 4;13(1):e12478. doi: 10.7759/cureus.12478.
Cardoso-de-Mello-E-Mello-Ribeiro AP, Rodriguez-Blanco C, Riquelme-Agullo I, Heredia-Rizo AM, Ricard F, Oliva-Pascual-Vaca A. Effects of the Fourth Ventricle Compression in the Regulation of the Autonomic Nervous System: A Randomized Control Trial. Evid Based Complement Alternat Med. 2015;2015:148285. doi: 10.1155/2015/148285. Epub 2015 Jun 14.
Chen YF, Huang XY, Chien CH, Cheng JF. The Effectiveness of Diaphragmatic Breathing Relaxation Training for Reducing Anxiety. Perspect Psychiatr Care. 2017 Oct;53(4):329-336. doi: 10.1111/ppc.12184. Epub 2016 Aug 23.
Consolo, K., Fusner, S., & Staib, S. (3 de Outubro de 2008). Effects of diaphragmatic breathing on stress levels of nursing students. pp. 67-71.
DiGiovanna , E., Schiowitz, S., & Dowling, D. (2020). An Osteopathic Approach to Diagnosis and Treatment, Fourth Edition. Lippincott Williams & Wilrins.
Homistek, C., & Doty, H. (2021). Insomnia Diagnosis and Management: An Osteopathic Approach. Osteopathic Family Physician, 31-36.
Lande RG, Gragnani C. Nonpharmacologic approaches to the management of insomnia. J Am Osteopath Assoc. 2010 Dec;110(12):695-701.
Liem, T., McPartland, J., & Skinner, E. (2005). Cranial Osteopathy - Principles and Practice. Elsevier Health Sciences.
Liu D, Kahathuduwa C, Vazsonyi AT. The Pittsburgh Sleep Quality Index (PSQI): Psychometric and clinical risk score applications among college students. Psychol Assess. 2021 Sep;33(9):816-826. doi: 10.1037/pas0001027. Epub 2021 May 20.
Manzar MD, BaHammam AS, Hameed UA, Spence DW, Pandi-Perumal SR, Moscovitch A, Streiner DL. Dimensionality of the Pittsburgh Sleep Quality Index: a systematic review. Health Qual Life Outcomes. 2018 May 9;16(1):89. doi: 10.1186/s12955-018-0915-x.
McCarley RW. Neurobiology of REM and NREM sleep. Sleep Med. 2007 Jun;8(4):302-30. doi: 10.1016/j.sleep.2007.03.005. Epub 2007 Apr 30.
Milnes, K., & Moran, R. (17 de Janeiro de 2007). Physiological effects of a CV4 cranial osteopathic technique on autonomic nervous system function: A preliminary investigation. pp. 8-17.
Morin M., C., Beaulieu-Bonneau, S., & Cheung, J. (2019). Treatment of Insomnia. Em Handbook of Sleep Disorders in Medical Conditions. Elsevier.
Pacheco, D., & Dimitriu, A. (2022). Symptoms of Insomnia.
Zitser J, Allen IE, Falgas N, Le MM, Neylan TC, Kramer JH, Walsh CM. Pittsburgh Sleep Quality Index (PSQI) responses are modulated by total sleep time and wake after sleep onset in healthy older adults. PLoS One. 2022 Jun 24;17(6):e0270095. doi: 10.1371/journal.pone.0270095. eCollection 2022.
Other Identifiers
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OST1_010
Identifier Type: -
Identifier Source: org_study_id
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