Osteopathic Protocol for Insomnia in College Students

NCT06363799 | Not Yet Recruiting

• 1 other identifier: OST1_010
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this randomized controlled experimental trial, it is aimed to determine the effectiveness of an osteopathic protocol treatment for insomnia in college students. In this study, will be used the Compression of 4th ventricle (CV4) and the diaphragmatic breathing technique.

Conditions

Insomnia

Keywords

CV4; Diaphragmatic breathing; Insomnia; Osteopathy; College Students

Outcome Measures

Primary Outcomes (1)

• Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score

  The insomnia episodes and symptoms are measured using the Pittsburgh questionnaire and it will be applied one month after the first intervention. It is expected that the Pittsburgh score decreases after the intervention is done. A Pittsburgh score higher than 5 is considered to be coincident with a bad sleeping quality. A Pittsburgh score lower than 5 is considered to be coincident with a good sleeping quality. This score goes up to 21 points.

  One month after the first intervention

Study Arms (3)

4th ventricle compression technique

EXPERIMENTAL

Experimental: 4th ventricle compression technique

Other: 4th ventricle compression technique

Diaphragmatic breathing technique

EXPERIMENTAL

Experimental: Diaphragmatic breathing technique

Other: Diaphragmatic breathing technique

Sham Tecnhique

PLACEBO COMPARATOR

Placebo Comparator: Sham Technique

Other: Sham Technique

Interventions

4th ventricle compression technique OTHER

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.

4th ventricle compression technique

Sham Technique OTHER

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.

Sham Tecnhique

Diaphragmatic breathing technique OTHER

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.

Diaphragmatic breathing technique

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• being a college student
• 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)

You may not qualify if:

• having suffered a stroke or aneurysm
• 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

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Related Publications (15)

• 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.

  PMID: 33425556 BACKGROUND

• 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.

  PMID: 26199632 BACKGROUND

• 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.

  PMID: 27553981 BACKGROUND

• Consolo, K., Fusner, S., & Staib, S. (3 de Outubro de 2008). Effects of diaphragmatic breathing on stress levels of nursing students. pp. 67-71.

  BACKGROUND

• DiGiovanna , E., Schiowitz, S., & Dowling, D. (2020). An Osteopathic Approach to Diagnosis and Treatment, Fourth Edition. Lippincott Williams & Wilrins.

  BACKGROUND

• Homistek, C., & Doty, H. (2021). Insomnia Diagnosis and Management: An Osteopathic Approach. Osteopathic Family Physician, 31-36.

  BACKGROUND

• Lande RG, Gragnani C. Nonpharmacologic approaches to the management of insomnia. J Am Osteopath Assoc. 2010 Dec;110(12):695-701.

  PMID: 21178150 BACKGROUND

• Liem, T., McPartland, J., & Skinner, E. (2005). Cranial Osteopathy - Principles and Practice. Elsevier Health Sciences.

  BACKGROUND

• 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.

  PMID: 34014747 BACKGROUND

• 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.

  PMID: 29743066 BACKGROUND

• 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.

  PMID: 17468046 BACKGROUND

• 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.

  BACKGROUND

• Morin M., C., Beaulieu-Bonneau, S., & Cheung, J. (2019). Treatment of Insomnia. Em Handbook of Sleep Disorders in Medical Conditions. Elsevier.

  BACKGROUND

• Pacheco, D., & Dimitriu, A. (2022). Symptoms of Insomnia.

  BACKGROUND

• 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.

  PMID: 35749529 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Natália MO Campelo, PhD

  Escola Superior da Saúde do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

+35122 206 1000; nmc@ess.ipp.pt

+35122 206 1000 Campelo, PhD

CONTACT

+35122 206 1000; nmc@ess.ipp.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04