Effects of an Osteopathic Treatment Protocol on Sleep Quality

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder
• Intervention / Treatment: Other: Osteopathic treatment protocol; Other: Sham 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 Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramón Mateos Alpuente; Phone Number: +34 620768645; Email: info@ramonmateos.es

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Recruiting
    • Ramón Mateos Fisioterapia y Osteopatía
    • Contact: Ramón Mateos Alpuente; Phone Number: +34 620768645; Email: info@ramonmateos.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Group of patients that will receive the 4 techniques proposed to evaluate the changes on sleep quality	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 Comparator: Control group; Group of patients that will receive a sham technique	Other: Sham technique; Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ramón Mateos Alpuente
• Investigators: Principal Investigator: Ramón Mateos Alpuente

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Stress; Heart Rate Variability; Sleep quality; Manual Therapy; Osteopathic Manipulative Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: SQ001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No