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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04955392
Other study ID # SQ001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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