Sensory and Behavioral Sleep Training

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.