Effects of an Osteopathic Treatment Protocol on Sleep Quality

Ramón Mateos Alpuente72 enrolled

Overview

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

Intervention protocol in the intervention group: The intervention protocol consists of 4 techniques that will be performed according to the following order: 1. Inhibition of the suboccipital muscles. 2. Parietal Lift. 3. Sutherland Technique of Sphenobasilar Synchondrosis. 4. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sleep Disorder

Interventions

Osteopathic treatment protocolOTHER

The intervention protocol consists of 4 techniques that will be performed according to the following order: 1. Inhibition of the suboccipital muscles. 2. Parietal Lift. 3. Sutherland Technique of Sphenobasilar Synchondrosis. 4. Compression technique of the fourth ventricle (CV4).

Sham techniqueOTHER

Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 1. Recent head injuries or fractures. 2. Having suffered a stroke or intracranial hemorrhage. 3. Tumors. 4. Epilepsy. 5. Bradycardia. 6. Hypotension. 7. Heart disease 8. Neurological problems 9. Psychiatric problems

Locations (1)

Ramón Mateos Fisioterapia y Osteopatía

Zaragoza, Spain

RECRUITING

Outcomes

Primary Outcomes

Sleep Quality

Sleep quality is measured using the Pittsburgh Sleep Quality Index before the intervention and one month after, having received three treatment sessions.

Time frame: 1 month

Secondary Outcomes

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

Time frame: 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.

Time frame: 1 month

Central Contacts

Ramón Mateos Alpuente

CONTACT

+34 620768645 info@ramonmateos.es

Data from ClinicalTrials.gov

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