Effects of Connective Tissue Massage in Patients With Chronic Insomnia

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

Interventions

PROCEDURE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• Turkey (Türkiye)

Study Locations