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

Sponsor

Escoles Universitaries Gimbernat (Other)

Overall Status

Recruiting

CT.gov ID

NCT05257317

Collaborator

Corporacion Parc Tauli (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Sleep Initiation and Maintenance Disorders	Other: Osteopathic Medicine Other: Placebo therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention It will consist of osteopathic manual therapy techniques applied to the occipital and temporal bones.	Other: 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 Comparator: Placebo It consists of a light contact applied to the cranial vault (frontal and parietal bones) where circular movements will be induced.	Other: Placebo therapy Circular movements will be induced in a frontal and parietal bones

Arm

Intervention/Treatment

Experimental: Intervention

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

Other: 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 Comparator: Placebo

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

Other: Placebo therapy

Circular movements will be induced in a frontal and parietal bones

Outcome Measures

Primary Outcome Measures

Insomnia Severity [18 weeks]
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).

Secondary Outcome Measures

Sleep Quality [18 weeks]
With a "Pittsburgh Sleep Quality Index (PSQI)" It consists of 19 items that analyze: quality, latency, duration, efficiency and sleep disturbances, use of sleeping medication and daytime dysfunction. The scores of the questions allows between 0 and 3 points for each of the seven subscales, where in all cases a score of "0" indicates ease, while a score of "3" indicates severe difficulty within its respective area. The sum of the seven subscales allows obtaining a global score between 0 and 21 for the entire scale, where "0" indicates ease of sleeping and "21" severe difficulty in all areas.
Sleep Quality [18 weeks]
With a "Cuestionario del Sueño de Oviedo (COS)". It consists of 15 items, 13 of which are grouped into 3 scales: Subjective sleep satisfaction (1 item): score from 1 to 7. Insomnia (9 items) The scoring range is from 9 to 45, higher score indicate greater severity. Hypersomnia (3 items): from 3 to 15 points, higher score indicate greater daytime disability.
Vulnerability to stress-related insomnia [9 weeks]
With FORD INSOMNIA RESPONSE TO STRESS spanish (FIRST-S). It is a scale that assesses vulnerability to stress-related insomnia. It is a standardized questionnaire with high test-retest reliability, which has been validated as a predictive measure of sleep vulnerability using polysomnographically measured sleep. It is made up of nine items and requires the individual to rate between 1 (not at all common) and 4 (very common) the probability of having sleep disturbance in association with specific and common stressful events or periods of stress that occur during the day or at night . The total score of the answers obtained is quantified. High scores are indicative of increased vulnerability to stress-related insomnia. The cut-off score to detect individuals with this vulnerability is 19 points or higher, indicating "high-FIRST sleep reactivity."
Quality of Life of patients with insomnia [18 weeks]
With a 12-items Short-Form Health Survey (SF12). It consists of 12 items from the 8 dimensions of the SF-36 Physical Function (2), Social Function (1), Physical Role (2), Emotional Role (2), Mental Health (2), Vitality (1), Body Pain (1), General Health (1). The response options form Likert-type scales that assess intensity or frequency. The number of response options ranges from three to six, depending on the item. For each of the 8 dimensions that it identifies, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst state of health for that dimension) to 100 (the best state of health).
Quantity, latency and efficiency of sleep [18 weeks]
With a "Sleep Diary"
Quantity, latency and efficiency of sleep [18 weeks]
With an "Actigraphy record"
Hypnogram-Polysomnography - Macro and microstructure of sleep [18 weeks]
With a "WachPAt(R) device"
Heart Rate Variability [4 weeks]
With a "Polar H10 band" and "EliteHRV" app

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Escoles Universitaries Gimbernat	Sant Cugat Del Vallès	Barcelona	Spain	08174

Sponsors and Collaborators

Escoles Universitaries Gimbernat
Corporacion Parc Tauli

Investigators

Principal Investigator: Maider Sánchez-Padilla, MSc, Escoles Universitaries Gimbernat
Study Director: Laura Vigil-Gimenez, PhD, Corporación Parc Taulí
Study Director: Maria José Masdeu-Margalef, PhD, Corporación Parc Taulí