Effects of an Osteopathic Treatment Protocol on Sleep Quality

Not Applicable

• Conditions: Sleep Disorder
• Interventions: Other: Sham technique; Other: Osteopathic treatment protocol

• Registration Number: NCT04955392
• Lead Sponsor: Ramón Mateos Alpuente

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-28
• Status Verified: 2021-07
• Study Start: 2021-07-01
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sham technique	Group of patients that will receive a sham technique
Intervention group	Osteopathic treatment protocol	Group of patients that will receive the 4 techniques proposed to evaluate the changes on sleep quality

Primary Outcome Measures

Name	Time	Method
Sleep Quality	1 month	Sleep quality is measured using the Pittsburgh Sleep Quality Index before the intervention and one month after, having received three treatment sessions.

Secondary Outcome Measures

Name	Time	Method
Heart Rate Variability	1 month	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
Perceived Stress	1 month	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.

Trial Locations

Locations (1)

Ramón Mateos Fisioterapia y Osteopatía; 🇪🇸 Zaragoza, Spain