Efficacy of Cranial Manual Therapy in the Treatment of Chronic Insomnia Disorder
NCT ID: NCT05257317
Last Updated: 2022-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-02-28
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
It will consist of osteopathic manual therapy techniques applied to the occipital and temporal bones.
Osteopathic Medicine
Where compression and traction movements will be carried out on these structures.
Technique called CV4, applied on the occipital, and Technique called asynchronous rolling of the temporal bones.
Placebo
It consists of a light contact applied to the cranial vault (frontal and parietal bones) where circular movements will be induced.
Placebo therapy
Circular movements will be induced in a frontal and parietal bones
Interventions
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Osteopathic Medicine
Where compression and traction movements will be carried out on these structures.
Technique called CV4, applied on the occipital, and Technique called asynchronous rolling of the temporal bones.
Placebo therapy
Circular movements will be induced in a frontal and parietal bones
Eligibility Criteria
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Inclusion Criteria
* Problems initiating or maintaining sleep, associated with daytime consequences; and not attributable to environmental circumstances.
* Insomnia lasting more than 3 months, with episodes of at least 3 times a week.
* Regarding the pharmacology or medication indicated for sleep:
* They do not want to take the medication recommended by the doctor who is treating them.
* Do not change their usual drug regimen, if they were already taking medication to sleep.
* They are not taxed to take medication.
* Having ruled out other pathologies related to sleep through:
* Respiratory polygraphy to rule out sleep-related respiratory pathologies (SAHS).
* screening to rule out motor sleep disorders.
* screening to rule out circadian sleep disorders.
* screening to rule out serious psychiatric disorders (depression, anxiety, general psychopathology): BDI-II (Beck Depression Inventory), BAI (Beck Anxiety Inventory), SCL-90.
* Obtain a score greater than 7 points (clinical-subclinical insomnia).
Exclusion Criteria
* The result of the respiratory polygraphy is positive, confirming a sleep-disordered breathing.
* The screening tests for the detection of motor sleep disorders, respiratory sleep disorders or circadian disorders are positive.
* The Screening detects serious psychiatric illnesses such as major depressive disorder or bipolar disorders is positive.
* Suffering or having suffered from any central neurological pathology, stroke, aneurysm...
* Having suffered skull fractures.
* Having undergone surgery in the last 6 months and that insomnia has started as a result of it.
18 Years
65 Years
ALL
No
Sponsors
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Corporacion Parc Tauli
OTHER
Escoles Universitaries Gimbernat
OTHER
Responsible Party
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Maider Sánchez Padilla
Principal Investigator
Principal Investigators
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Maider Sánchez-Padilla, MSc
Role: PRINCIPAL_INVESTIGATOR
Escoles Universitaries Gimbernat
Laura Vigil-Gimenez, PhD
Role: STUDY_DIRECTOR
Corporación Parc Taulí
Maria José Masdeu-Margalef, PhD
Role: STUDY_DIRECTOR
Corporación Parc Taulí
Locations
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Escoles Universitaries Gimbernat
Sant Cugat del Vallès, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2019/302
Identifier Type: -
Identifier Source: org_study_id
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