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

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Other: Suboccipital inhibition technique; Other: Placebo technique; Other: Frontal lift technique; Other: Parietal lift technique; Other: IV ventricle technique

• Registration Number: NCT05899972
• Lead Sponsor: Escola Superior de Tecnologia da Saúde do Porto

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.

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 Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-06-02
• Study First Posted: 2023-06-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Study Start: 2024-09-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Experimental group	Suboccipital inhibition technique	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.
Experimental: Experimental group	Frontal lift technique	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.
Experimental: Experimental group	IV ventricle technique	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.
Control group	Placebo technique	For the control group the placebo technique will be applied for 6 minutes.
Experimental: Experimental group	Parietal lift technique	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index	7 days post-intervention	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, measures several different aspects of sleep.

Trial Locations

Locations (1)

Escola Superior da Saúde do Porto; 🇵🇹 Porto, Portugal