Effects of an Osteopathic Treatment Protocol on Sleep Quality

Sleep Disorder Clinical Trial

Official title:

Effects of an Osteopathic Treatment Protocol on Sleep Quality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04955392
• Other study ID #: SQ001
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2021
• Source: Ramon Mateos Fisioterapia y Osteopatía
• Contact: Ramón Mateos Alpuente
• Phone: +34 620768645
• Email: info[@]ramonmateos.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• Osteopathic treatment protocol
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).
• Sham technique
Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.

Locations

Country	Name	City	State
Spain	Ramón Mateos Fisioterapia y Osteopatía	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Ramón Mateos Alpuente

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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