Effects of Connective Tissue Massage in Patients With Chronic Insomnia

N/ANot Yet RecruitingNCT07770945

Saglik Bilimleri Universitesi74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: From baseline to 4 weeks

Secondary Outcomes

Change in Cortisol Level

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.

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

Change in DHEA-S Level

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.

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

Change in Alpha-Amylase Level

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.

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

Change in Oxytocin Level

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.

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

Change in Total Sleep Time

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.

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

Change in Sleep Efficiency

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.

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

Change in Sleep Onset Latency

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

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.

Change in Wake After Sleep Onset (WASO)

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.

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

Change in Number of Nighttime Awakenings

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.

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

Change in Sleep Fragmentation Index

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.

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

Change in Pittsburgh Sleep Quality Index Score

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.

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

Change in Sleep Hygiene Index Score

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.

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

Effects of Connective Tissue Massage in Patients With Chronic Insomnia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts