Sensory and Behavioral Sleep Training

NCT07638605 | Recruiting

• 1 other identifier: Yazicioglu_1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep problems may affect individuals' daily functioning, emotional well-being, cognitive performance, and quality of life. Non-pharmacological approaches, including sleep hygiene education, sensory-based strategies, and behavioral relaxation techniques, may help individuals develop healthier sleep routines. However, studies directly comparing sensory-based and behavioral approaches are limited. The aim of this randomized controlled study is to compare the effects of sensory-based and behavioral sleep interventions in adults experiencing poor sleep quality. Participants are randomly assigned to one of three groups: a sleep hygiene education group, a sensory-based intervention group, or a behavioral intervention group. All participants receive a standardized six-week sleep hygiene education program. In addition, the sensory-based intervention group uses aromatherapy and pink noise, while the behavioral intervention group practices progressive muscle relaxation and diaphragmatic breathing exercises. Participants are assessed before and after the six-week intervention period. The study examines changes in sleep quality and sleep-related behaviors, as well as anxiety, quality of life, activity-role balance, sensory processing characteristics, autonomic nervous system activity, and sleep parameters. The study is expected to provide information about the potential contribution of sensory-based and behavioral strategies to the management of sleep problems.

Conditions

Sleep Disorder (Disorder)

Keywords

sleep disorder; sensory-based; behavioral

Outcome Measures

Primary Outcomes (2)

• Change in Pittsburgh Sleep Quality Index Global Score

  Sleep quality is assessed using the Pittsburgh Sleep Quality Index. The scale evaluates subjective sleep quality during the previous month and provides a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. The outcome is the change in the global score from baseline to the post-intervention assessment.

  Baseline and immediately after completion of the 6-week intervention

• Change in Sleep Hygiene Index Total Score

  Sleep hygiene is assessed using the Sleep Hygiene Index, which evaluates the frequency of behaviors and environmental practices that may negatively affect sleep. Higher total scores indicate poorer sleep hygiene. The outcome is the change in the total score from baseline to the post-intervention assessment.

  Baseline and immediately after completion of the 6-week intervention

Secondary Outcomes (5)

• Change in Beck Anxiety Inventory Total Score

  Baseline and immediately after completion of the 6-week intervention

• Change in WHOQOL-BREF Domain Scores

  Baseline and immediately after completion of the 6-week intervention

• Change in Occupational Balance Questionnaire-11 Total Score

  Baseline and immediately after completion of the 6-week intervention

• Change in Adolescent/Adult Sensory Profile Quadrant Scores

  Baseline and immediately after completion of the 6-week intervention

• Change in Resting Heart Rate Variability Parameters

  Baseline and immediately after completion of the 6-week intervention

Study Arms (3)

Sleep Hygiene Education

ACTIVE COMPARATOR

Participants in this group receive a standardized six-week sleep hygiene education program. The program includes recommendations on maintaining regular sleep and wake times, limiting caffeine, nicotine, and alcohol before bedtime, reducing stimulating activities and screen exposure, and arranging the sleep environment in terms of light, noise, and room temperature. Participants receive weekly follow-up telephone calls to support adherence to the program.

Behavioral: Sleep Hygiene Education

Sleep Hygiene Education Plus Sensory-Based Intervention

EXPERIMENTAL

Participants in this group receive the standardized six-week sleep hygiene education program together with a sensory-based intervention. The sensory intervention includes inhalation of lavender and orange essential oils before bedtime and exposure to pink noise during the transition to sleep. Participants receive standardized instructions for home-based application, and adherence is monitored through weekly follow-up telephone calls.

Behavioral: Sleep Hygiene Education; Behavioral: Sensory-Based Sleep Intervention

Sleep Hygiene Education Plus Behavioral Intervention

EXPERIMENTAL

Participants in this group receive the standardized six-week sleep hygiene education program together with a behavioral intervention. The behavioral intervention includes progressive muscle relaxation and diaphragmatic breathing exercises performed before bedtime. Participants receive written instructions and audio recordings to support standardized home-based practice, and adherence is monitored through weekly follow-up telephone calls.

Behavioral: Sleep Hygiene Education; Behavioral: Behavioral Relaxation Intervention

Interventions

Sleep Hygiene Education BEHAVIORAL

Participants receive a standardized six-week sleep hygiene education program. The program covers sleep physiology and the use of a sleep diary, the principles and importance of sleep hygiene, behavioral and cognitive strategies that may support sleep, characteristics of an appropriate sleep environment, evaluation of current sleep habits, factors affecting sleep quality, and reinforcement of acquired sleep-related behaviors. The educational content is delivered remotely, and adherence is supported through weekly telephone follow-up.

Sleep Hygiene Education; Sleep Hygiene Education Plus Behavioral Intervention; Sleep Hygiene Education Plus Sensory-Based Intervention

Sensory-Based Sleep Intervention BEHAVIORAL

Participants receive a home-based sensory intervention in addition to sleep hygiene education. The intervention includes inhalation of lavender and orange essential oils before bedtime and exposure to pink noise during the transition to sleep. Participants are instructed to apply a few drops of the essential oils to cotton or gauze placed at an appropriate distance for inhalation, or to disperse the oils into the room using a diffuser. The sensory strategies are introduced by the researcher and are applied regularly in the home environment throughout the six-week intervention period. Adherence is monitored through weekly telephone follow-up.

Sleep Hygiene Education Plus Sensory-Based Intervention

Behavioral Relaxation Intervention BEHAVIORAL

Participants receive a home-based behavioral relaxation intervention in addition to sleep hygiene education. The intervention consists of progressive muscle relaxation exercises and diaphragmatic breathing exercises performed before bedtime. Participants are provided with an audio recording and written instructions to support standardized practice. Progressive muscle relaxation involves the systematic relaxation of different muscle groups, while diaphragmatic breathing is used to support physiological relaxation. The exercises are practiced regularly throughout the six-week intervention period, and adherence is monitored through weekly telephone follow-up.

Sleep Hygiene Education Plus Behavioral Intervention

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 20 to 55 years
• Pittsburgh Sleep Quality Index global score of 5 or higher
• Able to use a smartphone
• Able to understand and speak Turkish
• Willing to participate voluntarily and provide informed consent

You may not qualify if:

• History of substance dependence
• Presence of a chronic physical illness or a diagnosed psychiatric disorder
• Regular medication use, particularly sleep-regulating medications, antidepressants, or similar medications that may affect sleep
• Diagnosis of a sleep disorder, such as insomnia or sleep apnea
• Mini-Mental State Examination score below 24
• Regular meditation or similar mind-body practice for more than 15 minutes per day
• Body mass index greater than 34.9 kg/m²
• Previous participation in a sleep hygiene education program

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Atlas University

Istanbul, Istanbul, 34672, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Behavior

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zeynep Çorakcı Yazıcıoğlu

CONTACT

+905376699979; zcorakci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants are randomly assigned in parallel to one of three study groups: sleep hygiene education alone, sleep hygiene education combined with a sensory-based intervention, or sleep hygiene education combined with a behavioral intervention. Each participant remains in the assigned group throughout the six-week intervention period, and outcomes are assessed before and after the intervention.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)