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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
Sponsored by
Escoles Universitaries Gimbernat
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
January 24, 2022
Last Updated
February 16, 2022
Sponsor
Escoles Universitaries Gimbernat
Collaborators
Corporacion Parc Tauli
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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).
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
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.
Time Frame
18 weeks
Title
Sleep Quality
Description
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.
Time Frame
18 weeks
Title
Vulnerability to stress-related insomnia
Description
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."
Time Frame
9 weeks
Title
Quality of Life of patients with insomnia
Description
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).
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
No
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
Email
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
Email
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
Email
maider.sanchez@eug.es

12. IPD Sharing Statement

Plan to Share IPD
No
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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Efficacy of Cranial Manual Therapy in the Treatment of Chronic Insomnia Disorder

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