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Osteopathic Protocol for Insomnia in College Students

Osteopathic Protocol for Insomnia in College Students: RCT

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06363799
Enrollment
20
Registered
2024-04-12
Start date
2024-09-30
Completion date
2024-12-31
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

CV4, Diaphragmatic breathing, Insomnia, Osteopathy, College Students

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.

Detailed description

Insomnia is a sleep disorder defined by persistent difficulty in initiating, maintaining or consolidating sleep. It can also be defined by early morning awakenings or having a dissatisfied sleep quality, even if you have plenty of time and a suitable environment to a restful sleep. This difficulty sleeping must be experienced at least 3 nights per week, for 3 consecutive months. This can often lead to symptoms such as fatigue, irritability and difficulty concentrating during the day. 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.

Interventions

OTHER4th 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.

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.

OTHERDiaphragmatic 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.

Sponsors

Escola Superior de Tecnologia da Saúde do Porto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 28 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire scoreOne month after the first interventionThe 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.

Contacts

Primary ContactNatália MO Campelo, PhD
nmc@ess.ipp.pt+35122 206 1000
Backup Contact+35122 206 1000 Campelo, PhD
nmc@ess.ipp.pt+35122 206 1000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026