Osteopathic Protocol for Insomnia in College Students

April 26, 2024 updated by: Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto

Osteopathic Protocol for Insomnia in College Students: RCT

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Natália MO Campelo, PhD
  • Phone Number: +35122 206 1000
  • Email: nmc@ess.ipp.pt

Study Contact Backup

  • Name: +35122 206 1000 Campelo, PhD
  • Phone Number: +35122 206 1000
  • Email: nmc@ess.ipp.pt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4th ventricle compression technique

Experimental:

4th ventricle compression technique
Other: 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.
Placebo Comparator: Sham Tecnhique

Placebo Comparator:

Sham Technique
Other: 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.
Experimental: Diaphragmatic breathing technique

Experimental:

Diaphragmatic breathing technique
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score
Time Frame: 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.
One month after the first intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escola Superior de Tecnologia da Saúde do Porto

Investigators

  • Principal Investigator: Natália MO Campelo, PhD, Escola Superior da Saúde do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OST1_010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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