NCT05257317

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Escoles Universitaries Gimbernat · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
OTHER	Placebo therapy	Circular movements will be induced in a frontal and parietal bones

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-12-01
• Completion: 2023-09-01
• First posted: 2022-02-25
• Last updated: 2022-02-25

Locations

1 site across 1 country: Spain