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Clinical Trials in Turkey / NCT07770945
Starting soon Not applicable

Effects of Connective Tissue Massage in Patients With Chronic Insomnia

NCT07770945 · tracked via the Priya Life Science Turkey tracker
Sponsor
Saglik Bilimleri Universitesi
Phase
Not applicable
Started
2026-09
Last updated
2026-08-18

Condition(s) studied

Chronic Insomnia

Investigational drug(s) / intervention(s)

Connective Tissue MassageSleep Hygiene Education

Connective Tissue Massage: Connective tissue massage will be administered by a physiotherapist three times per week for four consecutive weeks, for a total of 12 sessions.

Sleep Hygiene Education: Standardized sleep hygiene education based on clinical guidelines will be provided verbally by a neurologist following the baseline assessment, and the same content will be provided to participants in written brochure format.

Study summary

This randomized controlled trial will investigate the effects of connective tissue massage on insomnia severity, objective and subjective sleep outcomes, and stress- and autonomic-related biomarkers in adults with chronic insomnia. Chronic insomnia is a common sleep disorder characterized by persistent difficulties in initiating or maintaining sleep and is associated with impaired daytime functioning, reduced cognitive performance, and diminished quality of life. Non-pharmacological interventions may provide a safe alternative or complementary approach for individuals with chronic insomnia.

A total of 74 adults diagnosed with chronic insomnia by a neurologist and who have not used sleep medication during the previous four weeks will be enrolled. Participants will be randomly allocated to either a connective tissue massage group or a control group. The intervention group will receive 12 sessions of connective tissue massage over a four-week period, with three sessions per week, in addition to sleep hygiene education. The control group will receive sleep hygiene education alone.

Assessments will be performed at baseline and immediately after the four-week intervention period. The primary outcome will be the change in insomnia severity, assessed using the Insomnia Severity Index. Secondary outcomes will include objective sleep parameters recorded by actigraphy over five consecutive days, including total sleep time, sleep efficiency, sleep onset latency, and wake after sleep onset. Blood biomarkers associated with hypothalamic-pituitary-adrenal axis activity and autonomic regulation, including cortisol, DHEA-S, alpha-amylase, and oxytocin, will also be assessed. Subjective sleep quality and sleep hygiene will be evaluated using the Pittsburgh Sleep Quality Index and Sleep Hygiene Index, respectively. Adherence to sleep hygiene recommendations will additionally be assessed using sleep diaries.

The study aims to determine whether connective tissue massage combined with sleep hygiene education is more effective than sleep hygiene education alone in reducing insomnia severity and improving objective and subjective sleep outcomes and selected physiological biomarkers in adults with chronic insomnia.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Inclusion Criteria: * Adults aged 18 to 65 years, of either sex. * Diagnosis of chronic insomnia disorder according to the International -Classification of Sleep Disorders, Third Edition, Turkish version (ICSD-3-TR), established by a neurologist. * Difficulty initiating or maintaining sleep occurring at least three nights per week for at least three months, consistent with ICSD-3-TR diagnostic criteria. * No use of pharmacological agents for insomnia during the previous four weeks, including benzodiazepines, non-benzodiazepine hypnotics, melatonin and melatonin receptor agonists, sedating antidepressants, and anxiolytics. * Insomnia Severity Index score of ≥15, indicating moderate to severe insomnia. Ability to read and write. * Standardized Mini-Mental State Examination score of ≥24, indicating adequate cognitive status. * Willingness to participate in the study and provision of written informed consent. * Exclusion Criteria: * History of shift work during the previous month or lifestyle changes that may disrupt circadian rhythm. * Presence of obstructive sleep apnea syndrome, circadian rhythm sleep-wake disorders, or other primary sleep disorders. * History of any neurological diagnosis, such as epilepsy or Parkinson's disease, or psychiatric diagnosis, such as depression or bipolar disorder. * Presence of an open wound, infection, dermatitis, or other dermatological condition impairing skin integrity in the area where connective tissue massage will be applied. * Regular use of medications that may affect sleep, including antidepressants, beta-blockers, or corticosteroids. * Initiation of any pharmacological treatment for insomnia, including sleep medications or sedatives, during the four-week study period.

Primary outcome measure(s)

  • Change in Insomnia Severity Index Score — From baseline to 4 weeks
    Change in insomnia severity will be assessed using the Insomnia Severity Index (ISI). Assessments will be performed at baseline and immediately after the four-week intervention period.

Trial sites (1)

FacilityCityRegionStatus
Sultan 2.Abdulhamid Khan Educational and Research Hospital Istanbul Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07770945 on ClinicalTrials.gov ↗ ← All trials in Turkey