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Completed

NCT Number: NCT07638605

Sensory and Behavioral Sleep Training

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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlas University

Istanbul, 34672, Turkey (Türkiye)

About this study

This study is a three-arm, randomized controlled, single-blind trial designed to compare sensory-based and behavioral sleep interventions in individuals with poor sleep quality.

Eligible participants are randomly assigned to one of three parallel groups: a control group receiving standardized sleep hygiene education, a sensory-based intervention group, or a behavioral intervention group. Randomization is performed using a computer-generated random-number sequence. Attention is given to maintaining a balanced distribution of age and sex across the study groups. Because the researcher responsible for delivering the interventions is aware of group allocation, participant and intervention-provider blinding is not feasible. However, study data are coded and analyzed by an independent statistician who is blinded to group allocation.

All participants receive a standardized sleep hygiene education program lasting six weeks. The education addresses behavioral and environmental factors associated with sleep, including maintaining regular sleep and wake times, limiting caffeine, nicotine, and alcohol before bedtime, reducing exposure to stimulating activities, and arranging the sleep environment in terms of light, noise, and room temperature. Educational content is delivered through an online social media platform and supported by weekly telephone follow-up.

Participants allocated to the sensory-based intervention group receive the sleep hygiene education program together with sensory regulation strategies. These strategies include the inhalation of lavender and orange essential oils before sleep and exposure to pink noise during the transition to sleep. Participants are instructed in the standardized home-based use of these strategies, and adherence is monitored through weekly telephone calls.

Participants allocated to the behavioral intervention group receive the sleep hygiene education program together with progressive muscle relaxation and diaphragmatic breathing exercises. Audio recordings and written instructions are provided to support the standardized home-based practice of these techniques. Adherence is also monitored through weekly telephone calls.

The control group receives the standardized sleep hygiene education program without the additional sensory-based or behavioral components.

Assessments are conducted before the intervention and after completion of the six-week intervention period under standardized conditions. The primary focus of the study is the comparison of changes in sleep quality among the three groups. Additional assessments examine sleep hygiene, anxiety symptoms, quality of life, activity-role balance, sensory processing patterns, autonomic nervous system activity, and wearable-device-based sleep parameters.

Autonomic nervous system activity is assessed using heart rate variability recordings. Objective sleep parameters are monitored using a wearable activity-tracking device throughout the intervention period. Participants also maintain a daily sleep diary to record sleep-related routines and behaviors.

Intervention materials, application instructions, follow-up procedures, and assessment conditions are standardized across participants to support intervention fidelity and comparability. Participants are asked not to begin a new sleep-related treatment during the study period.

Study data are recorded using standardized data collection forms and participant identification codes. Data entries are reviewed for completeness, consistency, and values outside predefined ranges before statistical analysis. Where discrepancies are identified, entries are checked against the original assessment forms, sleep diaries, and device records. Access to identifiable information is restricted to authorized study personnel, and the analysis dataset is prepared in coded form. Missing data and protocol deviations are documented and addressed in accordance with the prespecified statistical analysis procedures.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change in Pittsburgh Sleep Quality Index Global Score

    Time frame: Baseline and immediately after completion of the 6-week intervention

    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.

  2. Change in Sleep Hygiene Index Total Score

    Time frame: Baseline and immediately after completion of the 6-week intervention

    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.

Secondary outcomes

  1. Change in Beck Anxiety Inventory Total Score

    Time frame: Baseline and immediately after completion of the 6-week intervention

    Anxiety symptoms are assessed using the 21-item Beck Anxiety Inventory. Each item is scored from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate greater anxiety symptom severity. The outcome is the change in the total score from baseline to the post-intervention assessment.

  2. Change in WHOQOL-BREF Domain Scores

    Time frame: Baseline and immediately after completion of the 6-week intervention

    Quality of life is assessed using the World Health Organization Quality of Life-BREF. The instrument evaluates physical health, psychological health, social relationships, and environmental quality of life. Domain scores are calculated separately, with higher scores indicating better quality of life. Changes in each domain score are evaluated.

  3. Change in Occupational Balance Questionnaire-11 Total Score

    Time frame: Baseline and immediately after completion of the 6-week intervention

    Occupational balance is assessed using the 11-item Occupational Balance Questionnaire. The total score ranges from 0 to 33. Higher scores indicate better perceived balance in the amount and variation of daily activities. The outcome is the change in the total score from baseline to the post-intervention assessment.

  4. Change in Adolescent/Adult Sensory Profile Quadrant Scores

    Time frame: Baseline and immediately after completion of the 6-week intervention

    Sensory processing patterns are assessed using the Adolescent/Adult Sensory Profile. The instrument evaluates four patterns: low registration, sensation seeking, sensory sensitivity, and sensation avoiding. Scores are calculated separately for each quadrant. Higher scores indicate more frequent behaviors associated with the relevant sensory processing pattern.

  5. Change in Resting Heart Rate Variability Parameters

    Time frame: Baseline and immediately after completion of the 6-week intervention

    Resting heart rate variability is recorded using a Polar H10 chest-strap sensor following a 5-minute seated rest period. Parameters include mean RR interval, heart rate, SDNN, RMSSD, pNN50, LF power, HF power, LF/HF ratio, normalized LF and HF power, and autonomic nervous system indices. Changes in each parameter are evaluated.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

A Comparison of Sensory and Behavioral Sleep Training in Individuals With Sleep Problems

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jul 21, 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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