NIPH Clinical Trials Search

Impact of rebound properties of mattress toppers on blood pressure in CPAP-treated obstructive sleep apnea patients: A randomized crossover trial

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	obstructive sleep apnea
Date of first enrollment	05/06/2026
Target sample size	36
Countries of recruitment
Study type	Interventional
Intervention(s)	High and low rebound mattress toppers

Outcome(s)

Primary Outcome

Morning home systolic blood pressure measured during each bedding use period

Secondary Outcome

1. Morning and bedtime heart rate during each bedding intervention period 2. Morning home diastolic blood pressure during each bedding intervention period 3. Bedtime home systolic and diastolic blood pressure during each bedding intervention period 4. Nocturnal mean systolic and diastolic blood pressure, 24-hour mean blood pressure, and nocturnal blood pressure dipping ratio obtained from ambulatory blood pressure monitoring (ABPM) performed during Week 4 of each bedding intervention period 5. Changes in total sleep time and sleep onset/awakening times assessed by sleep diary 6. Comparison of questionnaire scores: Athens Insomnia Scale and Pittsburgh Sleep Quality Index

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 75age old
Gender	Both
Include criteria	1. Patients who have received a full explanation of the study, have sufficient understanding of its contents, and have provided written informed consent of their own free will prior to participation. 2. Patients who are between 20 and 75 years of age at the time of obtaining informed consent. 3. Patients diagnosed with moderate to severe obstructive sleep apnea who are receiving home continuous positive airway pressure (CPAP) therapy and are under regular follow-up at the Department of Respiratory Medicine, Fujita Health University. 4. Patients whose home sleeping environment is adequately prepared and who have provided written informed consent to participate in the study. 5. Patients with an office systolic blood pressure of 130 mmHg or higher and/or an office diastolic blood pressure of 85 mmHg or higher 6. Any gender
Exclude criteria	1. Patients with poor CPAP adherence (defined as a proportion of nights with CPAP use over 4 hours of less than 70%) 2. Patients with predominant central sleep apnea or Cheyne Stokes respiration 3. Patients with residual events of 10 or more per hour (apnea hypopnea index of 10 events per hour or higher) under CPAP therapy 4. Patients with irregular sleep wake rhythms due to shift work or similar conditions 5. Patients with conditions that significantly affect hemodynamic stability, such as severe heart failure, unstable angina, or acute phase cerebrovascular disease 6. Patients with home blood pressure measurements over 180 100 mmHg 7. Patients who initiated a new antihypertensive medication or a medication with antihypertensive effects, or who changed the type or dosage of antihypertensive medication within the past 30 days 8. Patients with cognitive impairment or psychiatric symptoms that make it difficult to provide written informed consent or to record blood pressure measurements. 9. Patients who already routinely use a high-resilience (high rebound) mattress at home. 10. Patients with severe musculoskeletal or dermatological diseases that may be exacerbated by specific types of bedding and could compromise safety. 11. Female patients who are pregnant, breastfeeding, or planning to become pregnant during the study period. 12. Patients who are currently participating in another clinical trial or who have received an investigational drug within 30 days prior to enrollment. 13. Patients with any other condition that the principal investigator or sub-investigator judges to make participation unsafe or to significantly interfere with the conduct or evaluation of the study.