Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep Quality in Young Adults With Insomnia

Sponsor

Escola Superior de Tecnologia da Saúde do Porto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05899972

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sleep deprivation, which is a universal necessity, has serious physiological consequences.

Sleep disorders are among the most common health problems, and yet they are often neglected. The osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes. Thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Placebo technique Other: Suboccipital inhibition technique Other: Frontal lift technique Other: Parietal lift technique Other: IV ventricle technique	N/A

Detailed Description

Humans spend about a third of their lives sleeping, but most individuals know little about sleep. Sleep deprivation, which is a universal necessity, has serious physiological consequences.

Based on behavioral and physiological criteria, human sleep is divided into two phases: Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM).

NREM sleep corresponds to 75% to 80% of sleep and REM approximately 20% to 25% of sleep, existing between four to six episodes.

Sleep disorders are among the most common health problems, and yet they are often neglected. It is estimated that millions of people suffer chronically from a sleep or wakefulness disorder, impairing their health and longevity.

According to the International Classification of Sleep Disorders (ICSD) there are eight categories of sleep disorders and clinical history is essential for diagnosis, including family history, medical, psychiatric, neurological or substance abuse disorders.

Insomnia is a sleep disorder defined by difficulty falling asleep, staying asleep, or both. It can cause significant distress and impair daily tasks. The symptoms of insomnia are expressed by having difficulty falling asleep, waking up frequently during the night, waking up very early on a daily basis, and tiredness already present upon waking up.

Osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes (Henley, Ivins, Mills, Wen, & Benjamin, 2008). Thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

In the distribution of the volunteers to the groups, the participants chose between two numbered envelopes, opaque and sealed, in order to guarantee the confidentiality of the allocation, to which group they belonged. Inside each envelope is a piece of paper with the group, control group or intervention group.

Primary Purpose:

Other

Official Title:

Study of the Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep: a Double-blind Randomized Controlled Trial

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Experimental group The protocol is initiated by the suboccipital inhibition technique, with an average duration of three minutes. Afterwards, the frontal lift and parietal lift techniques were performed, which lasted an average of five minutes, being two and a half minutes for each one. Finally, the IV ventricle technique was performed, with an average duration of three minutes.	Other: Suboccipital inhibition technique With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator starts by placing both hands under the patient's head in the occipital region. After palpating the suboccipital muscles, the investigator uses the second, third and fourth fingers of both hands flexed against the muscle belly and remains in this position. Other: Frontal lift technique With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator positions the tips of both index fingers on either side of the metopic suture while the third finger remains resting on the frontal bone so that the tips of the fourth fingers contact the zygomatic processes bilaterally. A slight pressure is applied with the index fingers and an anterior pressure is performed. Other: Parietal lift technique With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator places the palms on the lateral edges of the parietal bones and the thumbs crossed at the sagittal suture. First, a medial pressure is administered with the second, third and fourth fingers and then a cephalic traction is performed. Other: IV ventricle technique With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator positions his hands in a shell and thumbs together at the level of the spinous apophyses of the patient's second or third cervical vertebra.
Placebo Comparator: Control group For the control group the placebo technique will be applied for 6 minutes.	Other: Placebo technique With the volunteer in a supine position, the researcher placed the palms of their hands on the patient's shoulders. The contact is made with the hands on the shoulder blades of the volunteer for 6 minutes.

Arm

Intervention/Treatment

Experimental: Experimental: Experimental group

The protocol is initiated by the suboccipital inhibition technique, with an average duration of three minutes. Afterwards, the frontal lift and parietal lift techniques were performed, which lasted an average of five minutes, being two and a half minutes for each one. Finally, the IV ventricle technique was performed, with an average duration of three minutes.

Other: Suboccipital inhibition technique

With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator starts by placing both hands under the patient's head in the occipital region. After palpating the suboccipital muscles, the investigator uses the second, third and fourth fingers of both hands flexed against the muscle belly and remains in this position.

Other: Frontal lift technique

With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator positions the tips of both index fingers on either side of the metopic suture while the third finger remains resting on the frontal bone so that the tips of the fourth fingers contact the zygomatic processes bilaterally. A slight pressure is applied with the index fingers and an anterior pressure is performed.

Other: Parietal lift technique

With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator places the palms on the lateral edges of the parietal bones and the thumbs crossed at the sagittal suture. First, a medial pressure is administered with the second, third and fourth fingers and then a cephalic traction is performed.

Other: IV ventricle technique

With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator positions his hands in a shell and thumbs together at the level of the spinous apophyses of the patient's second or third cervical vertebra.

Placebo Comparator: Control group

For the control group the placebo technique will be applied for 6 minutes.

Other: Placebo technique

With the volunteer in a supine position, the researcher placed the palms of their hands on the patient's shoulders. The contact is made with the hands on the shoulder blades of the volunteer for 6 minutes.

Outcome Measures

Primary Outcome Measures

Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index [14 days post-intervention]
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, measures several different aspects of sleep.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Have sleep disorders (insomnia);
Volunteers between 18 and 30 years of age.

Exclusion Criteria:

Attending the 3rd or 4th year of the Osteopathy Course;
Present fever (axillary or oral temperature higher than 37.5º C);
Have a history of skull fracture;
Have a history of bleeding and intracranial hemorrhage;
Have a diagnosis of convulsion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Escola Superior da Saúde do Porto	Porto		Portugal	4200-072

Sponsors and Collaborators

Escola Superior de Tecnologia da Saúde do Porto

Investigators

Principal Investigator: Natália MO Campelo, PhD, Escola Superior de Saúde do Politécnico do Porto

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2017

Publications

Responsible Party:

Natália Maria Oliveira Campelo, Professor, Escola Superior de Tecnologia da Saúde do Porto

ClinicalTrials.gov Identifier:

NCT05899972

Other Study ID Numbers:

OST1-007

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Natália Maria Oliveira Campelo, Professor, Escola Superior de Tecnologia da Saúde do Porto

Osteopathy

Insomnia

Sleep disorder

Study Results

No Results Posted as of Jun 18, 2023