Effects of an Osteopathic Treatment Protocol on Sleep Quality

NCT04955392 | Unknown

• 1 other identifier: SQ001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Disorder

Keywords

Sleep quality; Heart Rate Variability; Stress; Osteopathic Manipulative Treatment; Manual Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Heart Rate Variability

  1 month

• Perceived Stress

  1 month

Study Arms (2)

Intervention group

EXPERIMENTAL

Group of patients that will receive the 4 techniques proposed to evaluate the changes on sleep quality

Other: Osteopathic treatment protocol

Control group

SHAM COMPARATOR

Group of patients that will receive a sham technique

Other: Sham technique

Interventions

Osteopathic treatment protocol OTHER

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 group

Sham technique OTHER

Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ranging from 18 to 80 years old and with a score greater than 5 on the Pittsburgh Sleep Quality Index

You may not qualify if:

• Recent head injuries or fractures.
• Having suffered a stroke or intracranial hemorrhage.
• Tumors.
• Epilepsy.
• Bradycardia.
• Hypotension.
• Heart disease
• Neurological problems
• Psychiatric problems

Sponsors & Collaborators

• Ramón Mateos Alpuente: lead

Study Sites (1)

Ramón Mateos Fisioterapia y Osteopatía

Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Ramón Mateos Alpuente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramón Mateos Alpuente

CONTACT

+34 620768645; info@ramonmateos.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Eligible and recruited patients will be Randomized using OxMaR software (Oxford Minimization and Randomization).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: SIngle-centre interventional single-blinded randomized contsubjectsrolled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio)

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 8, 2021
• Study Start: July 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)