Osteopathic Protocol for Insomnia in College Students

Not Applicable

Not yet recruiting

• Conditions: Insomnia
• Interventions: Other: 4th ventricle compression technique; Other: Sham Technique; Other: Diaphragmatic breathing technique

• Registration Number: NCT06363799
• Lead Sponsor: Escola Superior de Tecnologia da Saúde do Porto

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-30
• Study Start: 2024-09
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4th ventricle compression technique	4th ventricle compression technique	Experimental: 4th ventricle compression technique
Sham Tecnhique	Sham Technique	Placebo Comparator: Sham Technique
Diaphragmatic breathing technique	Diaphragmatic breathing technique	Experimental: Diaphragmatic breathing technique

Primary Outcome Measures

Name	Time	Method
Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score	One month after the first intervention	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.