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NCT Number: NCT07770945

Effects of Connective Tissue Massage in Patients With Chronic Insomnia

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.

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Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan 2.Abdulhamid Khan Educational and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location contact

GULBALA GULOREN, PhD

CONTACT

[email protected]

+90 553 613 25 07

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Insomnia Severity Index Score

    Time frame: 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.

Secondary outcomes

  1. Change in Cortisol Level

    Time frame: From baseline to immediately after the 4-week intervention period

    Cortisol level will be assessed as a blood biomarker reflecting hypothalamic-pituitary-adrenal axis activity. The change from baseline to immediately after the 4-week intervention period will be evaluated.

  2. Change in DHEA-S Level

    Time frame: From baseline to immediately after the 4-week intervention period

    DHEA-S level will be assessed as a blood biomarker related to hypothalamic-pituitary-adrenal axis activity. The change from baseline to immediately after the 4-week intervention period will be evaluated.

  3. Change in Alpha-Amylase Level

    Time frame: From baseline to immediately after the 4-week intervention period

    Alpha-amylase level will be assessed as a blood biomarker related to autonomic regulation. The change from baseline to immediately after the 4-week intervention period will be evaluated.

  4. Change in Oxytocin Level

    Time frame: From baseline to immediately after the 4-week intervention period

    Oxytocin level will be assessed as a blood biomarker related to neuroendocrine and autonomic regulation. The change from baseline to immediately after the 4-week intervention period will be evaluated.

  5. Change in Total Sleep Time

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

    Total sleep time will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in total sleep time will be evaluated.

  6. Change in Sleep Efficiency

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

    Sleep efficiency will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in sleep efficiency will be evaluated.

  7. Change in Sleep Onset Latency

    Time frame: Sleep onset latency will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in sleep onset latency will be evaluated.

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

  8. Change in Wake After Sleep Onset (WASO)

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

    Wake after sleep onset (WASO) will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in WASO will be evaluated.

  9. Change in Number of Nighttime Awakenings

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

    The number of nighttime awakenings will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in the number of awakenings will be evaluated.

  10. Change in Sleep Fragmentation Index

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

    Sleep fragmentation index will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in sleep fragmentation index will be evaluated.

  11. Change in Pittsburgh Sleep Quality Index Score

    Time frame: From baseline to immediately after the 4-week intervention period

    Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The change in PSQI score from baseline to immediately after the 4-week intervention period will be evaluated.

  12. Change in Sleep Hygiene Index Score

    Time frame: From baseline to immediately after the 4-week intervention period

    Sleep hygiene behaviors will be assessed using the Sleep Hygiene Index (SHI). The change in SHI score from baseline to immediately after the 4-week intervention period will be evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

Nergis Yılmaz

CONTACT

[email protected]

+90 5318549782

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

The Effects of Connective Tissue Massage in Patients With Chronic Insomnia: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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