Clinical trial NCT05257317: Efficacy of Cranial Manual Therapy in the Treatment of Chronic Insomnia Disorder
Official title: Efficacy of Cranial Manual Therapy in the Treatment of Chronic Insomnia Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Sleep Iniciation and Maintenane Disorders
Autonomic Nervous System
Osteopathic Medicine
Muskuloeskeletal Manipulation
Dysominias
Lead sponsor: Escoles Universitaries Gimbernat
Sponsor class: OTHER
Collaborators: name: Corporacion Parc Tauli
First posted: 2022-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 of sleep; therefore, new pathways towards other adjuvant treatments are being established. OBJECTIVES: The main objective is "To assess the effectiveness of manual cranial therapy on the quantity and quality of sleep in patients with chronic insomnia." MATERIAL AND METHODS: A randomized clinical trial is designed, with two groups, intervention and placebo, to assess the effectiveness of manual therapy applied to the skull, in the severity of insomnia, and quantity and quality of sleep in patients with sleep disorder. chronic insomnia. Health professionals will be selected from the Department of Occupational Health, with characteristics of chronic insomnia described by the ICSD-III, who do not modify their usual medication regimen (if they take it) and without other pathologies related to sleep that may be causing the insomnia. insomnia Demographic data (age, sex, profession), clinical (BMI, history of previous and family insomnia pathologies, and taking medication for sleep and related disorders), sleep quality questionnaires (PSQI, COS, ISI) will be collected. , stress-insomnia relationship (FISRST-S), and quality of life (SF12), in addition to filling out a sleep diary (through the mobile App) and recording activity through actigraphy, hypnogram (Sleep ProfilerTM); before and after the intervention, and at one and three month follow-up. Each group will receive the offered intervention: cranial manual therapy (intervention) or cranial massage (placebo). The data will be coded and analyzed with the IBM SPSS® version 20 program (or similar)


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Insomnia Severity
timeFrame: 18 weeks
Secondary outcomes:
measure: Sleep Quality
timeFrame: 18 weeks
measure: Sleep Quality
timeFrame: 18 weeks
measure: Vulnerability to stress-related insomnia
timeFrame: 9 weeks
measure: Quality of Life of patients with insomnia
timeFrame: 18 weeks
measure: Quantity, latency and efficiency of sleep
timeFrame: 18 weeks
measure: Quantity, latency and efficiency of sleep
timeFrame: 18 weeks
measure: Hypnogram-Polysomnography - Macro and microstructure of sleep
timeFrame: 18 weeks
measure: Heart Rate Variability
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Escoles Universitaries Gimbernat
state: Barcelona
Study officials:
affiliation: Escoles Universitaries Gimbernat
name: Maider Sánchez-Padilla, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporación Parc Taulí
name: Laura Vigil-Gimenez, PhD
role: STUDY_DIRECTOR
affiliation: Corporación Parc Taulí
name: Maria José Masdeu-Margalef, PhD
role: STUDY_DIRECTOR
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