Sleep DisorderNCT04955392
Effects of an Osteopathic Treatment Protocol on Sleep Quality
A study testing Osteopathic treatment protocol in people with Sleep Disorder, run by Ramón Mateos Alpuente at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Osteopathic treatment protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ranging from 18 to 80 years old and with a score greater than 5 on the Pittsburgh Sleep Quality Index
Who cannot join
- Recent head injuries or fractures.
- Having suffered a stroke or intracranial hemorrhage.
- Tumors.
- Epilepsy.
- Bradycardia.
- Hypotension.
Show all 9Show fewer
- Heart disease
- Neurological problems
- Psychiatric problems
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Ramón Mateos Fisioterapia y Osteopatía
Zaragoza, 50009
Ramón Mateos Alpuente, +34 620768645, info@ramonmateos.es
About this study
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
Read the detailed description
Intervention protocol in the intervention group:
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).
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.
- Conditions
- Sleep Disorder
- Being tested
- Osteopathic treatment protocol, Sham technique
- Keywords
- Sleep quality, Heart Rate Variability, Stress, Osteopathic Manipulative Treatment, Manual Therapy
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic treatment protocolOther
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 techniqueOther
Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group of patients that will receive the 4 techniques proposed to evaluate the changes on sleep quality Receives: Other: Osteopathic treatment protocol |
| Control group | Sham comparator | Group of patients that will receive a sham technique Receives: Other: Sham technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep quality is measured using the Pittsburgh Sleep Quality Index before the intervention and one month after, having received three treatment sessions.
Measured: 1 month
Secondary outcomes (2)
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
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jul 2021
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramón Mateos Alpuente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ramón Mateos Alpuente, Ramon Mateos Fisioterapia y Osteopatía
- Investigators
- Ramón Mateos Alpuente, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955392
- Sponsor's protocol ID
- SQ001
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Osteopathic Treatment Protocol on Sleep Quality
- ClinicalTrials.gov ID
- NCT04955392
- Acronym / sponsor ID
- SQ001
- Conditions
- Sleep Disorder
- Keywords
- Sleep quality, Heart Rate Variability, Stress, Osteopathic Manipulative Treatment, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ramón Mateos AlpuenteUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Inhibition of the suboccipital muscles.
- Parietal Lift.
- Sutherland Technique of Sphenobasilar Synchondrosis.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Osteopathic treatment protocolGroup of patients that will receive the 4 techniques proposed to evaluate the changes on sleep quality |
| Control group | Sham comparator | Other: Sham techniqueGroup of patients that will receive a sham technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults ranging from 18 to 80 years old and with a score greater than 5 on the Pittsburgh Sleep Quality Index
Key exclusion criteria (9 listed)
- Recent head injuries or fractures.
- Having suffered a stroke or intracranial hemorrhage.
- Tumors.
- Epilepsy.
- Bradycardia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic treatment protocolThe 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). | Other | Intervention group |
| Sham techniqueSham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes. | Other | Control group |
Primary outcome
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.
2 secondary outcomes
Heart Rate Variability
Time frame: 1 month
Perceived Stress
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramón Mateos Alpuente principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic treatment protocol in people with Sleep Disorder, run by Ramón Mateos Alpuente at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramón Mateos Alpuente (+34 620768645, info@ramonmateos.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.