Effects of Connective Tissue Massage in Patients With Chronic Insomnia

NCT07770945 | Not Yet Recruiting

• 2 other identifiers: CTM-INSOMNIA-2026-01226S838
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Insomnia

Keywords

Sleep; quality of sleep; Physiotherapy And Rehabilitation; Alpha Amylase; Sleep Disorders; Massage; Oxytocin; Physiotherapy; Cortisol

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index Score

  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.

  From baseline to 4 weeks

Secondary Outcomes (12)

• Change in Cortisol Level

  From baseline to immediately after the 4-week intervention period

• Change in DHEA-S Level

  From baseline to immediately after the 4-week intervention period

• Change in Alpha-Amylase Level

  From baseline to immediately after the 4-week intervention period

• Change in Oxytocin Level

  From baseline to immediately after the 4-week intervention period

• Change in Total Sleep Time

  From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.

Study Arms (2)

Connective Tissue Massage + Sleep Hygiene Education

EXPERIMENTAL

Participants will receive standardized sleep hygiene education provided verbally by a neurologist and as a written brochure, in addition to 12 sessions of connective tissue massage delivered by a physiotherapist over four weeks, three sessions per week.

Procedure: Connective Tissue Massage; Behavioral: Sleep Hygiene Education

Sleep Hygiene Education

ACTIVE COMPARATOR

Participants will receive standardized sleep hygiene education provided verbally by a neurologist and as a written brochure. No connective tissue massage will be provided during the four-week study period.

Behavioral: Sleep Hygiene Education

Interventions

Sleep Hygiene Education BEHAVIORAL

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.

Connective Tissue Massage + Sleep Hygiene Education; Sleep Hygiene Education

Connective Tissue Massage PROCEDURE

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

Connective Tissue Massage + Sleep Hygiene Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sultan 2.Abdulhamid Khan Educational and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nergis Yılmaz

CONTACT

+90 5318549782; nergis-yilmaz39@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be randomly allocated in a 1:1 ratio to either the connective tissue massage plus sleep hygiene education group or the sleep hygiene education-only control group. Both groups will undergo assessments at baseline and immediately after the four-week intervention period.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

TU (1)