Effects of an Osteopathic Treatment Protocol on Sleep Quality

Study Overview
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Brief Summary
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SIngle-centre interventional single-blinded randomized controlled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio) and to be carried out with volunteers that present alterations in the quality of sleep. Eligible and accepting subjects participating in the study will be assigned to receive an osteopathic treatment protocol or a placebo technique

Detailed Description
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Intervention protocol in the intervention group: The intervention protocol consists of 4 techniques that will be performed according to the following order: Inhibition of the suboccipital muscles. Parietal Lift. Sutherland Technique of Sphenobasilar Synchondrosis. Compression technique of the fourth ventricle (CV4). Intervention protocol in the control group: Placebo technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.

Official Title
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Effects of an Osteopathic Treatment Protocol on Sleep Quality

Conditions
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Sleep Disorder

Intervention / Treatment
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* Other: Osteopathic treatment protocol
* Other: Sham technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ranging from 18 to 80 years old and with a score greater than 5 on the Pittsburgh Sleep Quality Index Exclusion Criteria: Recent head injuries or fractures. Having suffered a stroke or intracranial hemorrhage. Tumors. Epilepsy. Bradycardia. Hypotension. Heart disease Neurological problems Psychiatric problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SIngle-centre interventional single-blinded randomized contsubjectsrolled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Group of patients that will receive the 4 techniques proposed to evaluate the changes on sleep quality | Other: Osteopathic treatment protocol<br>* The intervention protocol consists of 4 techniques that will be performed according to the following order: Inhibition of the suboccipital muscles. Parietal Lift. Sutherland Technique of Sphenobasilar Synchondrosis. Compression technique of the fourth ventricle (CV4).<br>|
| Sham Comparator: Control group<br>Group of patients that will receive a sham technique | Other: Sham technique<br>* Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Sleep quality is measured using the Pittsburgh Sleep Quality Index before the intervention and one month after, having received three treatment sessions. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability | Changes in Heart Rate Variability (HRV) that will be measured and monitored before and at the end of the intervention using a portable HRV monitoring device (polar H10) that sends the signal to a computer for its collection and analysis through the Kubios HRV software | 1 month | 
| Perceived Stress | Assessment of perceived stress using the Cohen's Perceived Stress Scale (PSS), which will be completed before the first intervention and one week after completing the three planned interventions. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Osteopathic Manipulative Treatment, Manual Therapy, Sleep quality, Heart Rate Variability