Clinical trial NCT05899972: Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep Quality in Young Adults With Insomnia
Official title: Study of the Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Osteopathy
Insomnia
Sleep disorder
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index
timeFrame: 7 days post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior da Saúde do Porto
Study officials:
affiliation: Escola Superior de Saúde do Politécnico do Porto
name: Natália MO Campelo, PhD
role: PRINCIPAL_INVESTIGATOR
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