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

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Osteopathic Medicine

Placebo therapy

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Sleep Iniciation and Maintenane Disorders, Autonomic Nervous System, Osteopathic Medicine, Muskuloeskeletal Manipulation, Dysominias

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Escoles Universitaries GimbernatRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Sleep Quality

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

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

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

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

With a "Sleep Diary"

Quantity, latency and efficiency of sleep

With an "Actigraphy record"

Hypnogram-Polysomnography - Macro and microstructure of sleep

With a "WachPAt(R) device"

Heart Rate Variability

With a "Polar H10 band" and "EliteHRV" app

Full Information

NCT ID

NCT05257317

First Posted

January 24, 2022

Last Updated

February 16, 2022

Sponsor

Escoles Universitaries Gimbernat

Collaborators

Corporacion Parc Tauli

1. Study Identification

Unique Protocol Identification Number

NCT05257317

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 2022 (Anticipated)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Escoles Universitaries Gimbernat

Collaborators

Corporacion Parc Tauli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Initiation and Maintenance Disorders

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Osteopathic Medicine

Intervention Description

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 Type

Other

Intervention Name(s)

Placebo therapy

Intervention Description

Circular movements will be induced in a frontal and parietal bones

Primary Outcome Measure Information:

Title

Insomnia Severity

Description

Time Frame

18 weeks

Secondary Outcome Measure Information:

Title

Sleep Quality

Description

Time Frame

18 weeks

Title

Sleep Quality

Description

Time Frame

18 weeks

Title

Vulnerability to stress-related insomnia

Description

Time Frame

9 weeks

Title

Quality of Life of patients with insomnia

Description

Time Frame

18 weeks

Title

Quantity, latency and efficiency of sleep

Description

With a "Sleep Diary"

Time Frame

18 weeks

Title

Quantity, latency and efficiency of sleep

Description

With an "Actigraphy record"

Time Frame

18 weeks

Title

Hypnogram-Polysomnography - Macro and microstructure of sleep

Description

With a "WachPAt(R) device"

Time Frame

18 weeks

Title

Heart Rate Variability

Description

With a "Polar H10 band" and "EliteHRV" app

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maider Sánchez-Padilla, MSc

Phone

0034 93 589 37 27

Ext

216

maider.sanchez@eug.es

First Name & Middle Initial & Last Name or Official Title & Degree

Jordi Esquirol-Caussa, PhD

Phone

0034 93 589 37 27

Ext

238

jordi.esquirol@eug.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maider Sánchez-Padilla, MSc

Organizational Affiliation

Escoles Universitaries Gimbernat

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Laura Vigil-Gimenez, PhD

Organizational Affiliation

Corporación Parc Taulí

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Maria José Masdeu-Margalef, PhD

Organizational Affiliation

Corporación Parc Taulí

Official's Role

Study Director

Facility Information:

Facility Name

Escoles Universitaries Gimbernat

City

Sant Cugat Del Vallès

State/Province

Barcelona

ZIP/Postal Code

08174

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maider Sánchez-Padilla, MSc

Phone

0034 93 589 37 27

Ext

216

maider.sanchez@eug.es

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The pandemic has delayed the completion of the study and no publication date for the information has been proposed

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Miana L, Bastos VH, Machado S, Arias-Carrion O, Nardi AE, Almeida L, Ribeiro P, Machado D, King H, Silva JG. Changes in alpha band activity associated with application of the compression of fourth ventricular (CV-4) osteopathic procedure: a qEEG pilot study. J Bodyw Mov Ther. 2013 Jul;17(3):291-6. doi: 10.1016/j.jbmt.2012.10.002. Epub 2012 Nov 16.

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

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