Effects of an Osteopathic Treatment Protocol on Sleep Quality

July 7, 2021 updated by: Ramón Mateos Alpuente
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Recruiting
        • Ramón Mateos Fisioterapia y Osteopatía
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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:

  1. Inhibition of the suboccipital muscles.
  2. Parietal Lift.
  3. Sutherland Technique of Sphenobasilar Synchondrosis.
  4. 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
Time Frame: 1 month
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
Time Frame: 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
1 month
Perceived Stress
Time Frame: 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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramón Mateos Alpuente

Investigators

  • Principal Investigator: Ramón Mateos Alpuente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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