Effects of acute exercise on cardiovascular and respiratory function in patients with obstructive sleep apnea syndrome.

UMIN ID: UMIN000054042

Registered date:03/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Obstructive sleep apnea syndrome Healthy adults
• Date of first enrollment: 2023/08/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Inspiratory muscle exercise Inspiratory muscle loading device Target intensity: 70-75% of maximal inspiratory mouth pressure Frequency and time: 5 sets of 6 breaths with 2 min set rest, a total of 10.5 min Inspiration and expiration durations during exercise: 2 sec and 3 sec
Inspiratory muscle exercise Inspiratory muscle loading device Target intensity: 10-15% of maximal inspiratory mouth pressure Frequency and time: 5 sets of 6 breaths with 2 min set rest, a total of 10.5 min Inspiration and expiration durations during exercise: 2 sec and 3 sec To perform only healthy adults

Outcome(s)

• Primary Outcome: Flow-mediated dilation
• Secondary Outcome: Maximum inspiratory mouth pressure Maximum expiratory mouth pressure Forced vital capacity Forced expiratory volume in 1 second Cerebrovascular CO2 reactivity

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Currently have or are being treated for any of the following Chronic heart failure, asthma, restricting and obstructive ventilation disorders, central and peripheral nervous system disorders, diabetes mellitus (HbA1c > 7%), hypothyroidism, immunodeficiency disorders Head, neck, or chest surgery within the past 3 years Body Mass Index (BMI) greater than 40 or less than 18.5 Apnea Hypopnea Index (AHI) greater than 15 during treatment within the past year Mixed (obstructive and central) sleep apnea Resting blood pressure greater than 160/100 mmHg or less than 100/60 mmHg Exercise at least 5 times a week at a moderate intensity or higher Current smokers, <Healthy adults> Subjects who have smoked within the past 5 years. <Women> Currently undergoing hormone therapy

Related Information

• Primary Sponsor: Sapporo Medical University
• Source(s) of Monetary Support: MEXT(Japan)