Status:
UNKNOWN
Efficacy of Cranial Manual Therapy in the Treatment of Chronic Insomnia Disorder
Lead Sponsor:
Escoles Universitaries Gimbernat
Collaborating Sponsors:
Corporacion Parc Tauli
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Insomnia is the most prevalent sleep disorder in society. The first treatment of choice is pharmacology, although it can have secondary effects such as tolerance and dependence, or alter the structure...
Eligibility Criteria
Inclusion
- Diagnosed with chronic insomnia disorder according to the criteria defined by the ICSD-III (International Classification of Sleep Disorders-3rd edition):
- 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
- Obtain a score of less than 7 (clinically insignificant insomnia) in the ISI test (Insomnia Severity Index).
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05257317
Start Date
February 1 2022
End Date
September 1 2023
Last Update
February 25 2022
Active Locations (1)
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1
Escoles Universitaries Gimbernat
Sant Cugat del Vallès, Barcelona, Spain, 08174