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Osteopathic Protocol for Insomnia in College Students

E

Escola Superior de Tecnologia da Saúde do Porto

Status

Not yet enrolling

Conditions

Insomnia

Treatments

Other: Sham Technique
Other: Diaphragmatic breathing technique
Other: 4th ventricle compression technique

Study type

Interventional

Funder types

Other

Identifiers

NCT06363799
OST1_010

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 28 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 3 patient groups, including a placebo group

4th ventricle compression technique
Experimental group
Description:
Experimental: 4th ventricle compression technique
Treatment:
Other: 4th ventricle compression technique
Diaphragmatic breathing technique
Experimental group
Description:
Experimental: Diaphragmatic breathing technique
Treatment:
Other: Diaphragmatic breathing technique
Sham Tecnhique
Placebo Comparator group
Description:
Placebo Comparator: Sham Technique
Treatment:
Other: Sham Technique

Trial contacts and locations

0

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Central trial contact

+35122 206 1000 Campelo, PhD; Natália MO Campelo, PhD

Data sourced from clinicaltrials.gov

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