Efficacy of Cranial Manual Therapy in the Treatment of Chronic Insomnia Disorder

NCT05257317 | Unknown

• 1 other identifier: 2019/302
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Sleep Iniciation and Maintenane Disorders; Autonomic Nervous System; Osteopathic Medicine; Muskuloeskeletal Manipulation; Dysominias

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity

  With an "Insomnia Severity Index" (ISI). There are seven items. Each item is rated on a scale from 0 to 4 from less to more severe. The total score is the sum of each individual item and can range from 0 to 28 (28 = most severe insomnia).

  18 weeks

Secondary Outcomes (8)

• Sleep Quality

  18 weeks

• Sleep Quality

  18 weeks

• Vulnerability to stress-related insomnia

  9 weeks

• Quality of Life of patients with insomnia

  18 weeks

• Quantity, latency and efficiency of sleep

  18 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

It will consist of osteopathic manual therapy techniques applied to the occipital and temporal bones.

Other: Osteopathic Medicine

Placebo

PLACEBO COMPARATOR

It consists of a light contact applied to the cranial vault (frontal and parietal bones) where circular movements will be induced.

Other: Placebo therapy

Interventions

Osteopathic Medicine OTHER

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.

Intervention

Placebo therapy OTHER

Circular movements will be induced in a frontal and parietal bones

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escoles Universitaries Gimbernat: lead
• Corporacion Parc Tauli: collaborator

Study Sites (1)

Escoles Universitaries Gimbernat

Sant Cugat del Vallès, Barcelona, 08174, Spain

RECRUITING

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Maider Sánchez-Padilla, MSc

  Escoles Universitaries Gimbernat

  PRINCIPAL INVESTIGATOR

• Laura Vigil-Gimenez, PhD

  Corporación Parc Taulí

  STUDY DIRECTOR

• Maria José Masdeu-Margalef, PhD

  Corporación Parc Taulí

  STUDY DIRECTOR

Central Study Contacts

Maider Sánchez-Padilla, MSc

CONTACT

0034 93 589 37 27; maider.sanchez@eug.es

Jordi Esquirol-Caussa, PhD

CONTACT

0034 93 589 37 27; jordi.esquirol@eug.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 25, 2022
• Study Start: February 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: September 1, 2023
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)