None listed
Conditions
Brief summary
Obstructive sleep apnoea (OSA) is a prevalent disorder that affects 1 in 7 people globally. The most significant risk factor for OSA is obesity, which is increasing to epidemic levels. Nearly 70% of people with OSA are overweight or obese. It is well established that obesity contributes to OSA by promoting increased collapsibility of the upper airway anatomy. However, recent evidence suggests that several non-anatomical factors contribute to OSA. These non-anatomical traits are an oversensitive ventilatory control system (i.e. ventilatory control instability or high loop gain), poor pharyngeal muscle response and a low respiratory arousal threshold. However, it is currently unclear how obesity and, by extension, weight loss alters these traits. Weight-loss interventions such as exercise are continually recommended as a means of managing both OSA and the cardio-metabolic complications associated with obesity. Exercise interventions have been shown to modestly improve OSA severity, and improve daytime sleepiness, sleep quality and quality of life, even without significant changes in body weight in some studies. However, the mechanisms underlying the improvements in OSA severity are currently unknown. Recently, several studies have shown that increasing the work of breathing through playing musical instruments, or upper airway muscle exercises can lead to improvements in OSA severity. Based on these findings, it is assumed that the increased work of breathing strengthens the upper airway muscles and thereby reduces OSA severity. Therefore, this study will examine how high intensity exercise affects the underlying physiological mechanisms responsible for OSA. Therefore, we hypothesise that OSA improvements following exercise are driven by improvements in upper airway muscle response. As such, we hypothesise that high intensity interval training (HIIT) will result in improvements in OSA severity.
Interventions
The GASP study will investigate a high intensity interval training intervention on the pathophysiology of obstructive sleep apnoea (OSA). Participants will complete a 12- week program consisting of: 1) 2 non-consecutive supervised exercise sessions per week and; 2) a total of 90 minutes of walking at a comfortable pace per week in their own time. The 2 non-consecutive supervised exercise sessions will be in person at a training facility and will be conducted and supervised by a study team member in groups of 1 - 8 participants. Each session will begin with the participant doing a 5-minute warm up on a cycle ergometer. The participant will then do 4 repetitions on the cycle ergometer of 3-minutes at >80% HRmax and then resting for 3 minutes. The total time of the exercise session will be ~30 minutes. To ensure the target HR zone is achieved and maintained study staff will monitor adherence using heart rate telemetry. The speed of the cycle ergometer will be adjusted to ensure the target heart rate is achieved and maintained. The target heart rate zones will be calculated for each participant based on the results of their pre-intervention fitness tests. In addition to attending group training sessions, participants will walk for 90 minutes each week at home in their own time. The 90 minutes may be divided up into durations of their own choosing (i.e., 3 x 30 min sessions per week, 2 x 45 min sessions per week) so long as it totals 90 minutes each week. Each walking session will be done at a comfortable pace (the participant can still hold a conversation). Participants will be given a Fitbit Charge 5 device to measure sleep and activity. They will wear the Fitbit device for 1 week prior to beginning the intervention, for the 12- weeks of the intervention and for 1 week after the intervention ends for a total of 14 weeks. The Fitbit device will also be used to monitor adherence to the at home walking sessions. Participants will receive a progress/ motivational text message 1 time per week for the 12- week intervention. Patient's sleep (i.e. OSA severity) and physiological traits will be assessed via two overnight sleep studies before and after the intervention in order to assess how exercise impacts OSA and its underlying physiology. Patients cardiorespiratory fitness will also be assessed pre and post intervention.
Sponsors
Study design
Eligibility
Inclusion criteria
-Moderate/severe OSA (10 =>AHI <= 50 events/hr) -Overweight (25 >= BMI <= 35 kg/m2) -Engaged in less than or equal to 5 sessions of high intensity training within in the past 6 months -Physical activity levels have remained below the following in the past three months -<150 minutes of moderate-intensity activity or walking in a typical week; and -<75 minutes of vigorous-intensity activity in a typical week -At stable medication doses (for greater than 3 months) -Diagnosed with OSA and not currently using OSA treatment or are willing to abstain from using OSA treatment for the duration of the study. -Epworth Sleepiness Scale (ESS) greater than 16 at screening -Not actively trying to lose weight
Exclusion criteria
-Known or suspected significant cardiovascular, pulmonary, or metabolic disease -Uncontrolled hypertension (>159/99 mm Hg) -Patients with safety concerns (drowsy driving within the past 2 years) -Receiving medication that could affect ventilation (i.e., morphine derivatives, benzodiazepines, theophylline) or muscle control. -Previous surgical treatment for OSA and/or obesity -Women who are pregnant or currently trying to become pregnant -Inability to exercise due to orthopaedic or musculoskeletal problems -Score below 2 on the STOP Bang Questionnaire -Allergy to any of the local anaesthetics used to insert the genioglossus intramuscular electrodes (e.g. Lidocaine, Lidocaine–Prilocaine). The local anaesthetic is used to reduce the the potential pain or discomfort caused by the insertion of the intramuscular electrodes during the polysomnography which is part of the assessment of study outcomes.