Sleep Disorder
Conditions
Keywords
Sleep quality, Heart Rate Variability, Stress, Osteopathic Manipulative Treatment, Manual Therapy
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
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.
Interventions
OTHEROsteopathic 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).
OTHERSham technique
Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.
Sponsors
Ramón Mateos Alpuente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Eligible and recruited patients will be Randomized using OxMaR software (Oxford Minimization and Randomization).
Intervention model description
SIngle-centre interventional single-blinded randomized contsubjectsrolled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 1 month | Sleep quality is measured using the Pittsburgh Sleep Quality Index before the intervention and one month after, having received three treatment sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability | 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 |
| Perceived Stress | 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. |
Countries
Spain
Contacts
Primary ContactRamón Mateos Alpuente
Outcome results
None listed