Clinical trial NCT06363799: Osteopathic Protocol for Insomnia in College Students
Official title: Osteopathic Protocol for Insomnia in College Students: RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: CV4
Diaphragmatic breathing
Insomnia
Osteopathy
College Students
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score
timeFrame: One month after the first intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Escola Superior da Saúde do Porto
name: Natália MO Campelo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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