Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467682
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-26
Brief Title:
12-week Tele-exercise Program in Patients With OSA
Sponsor:
University of Cyprus
Organization:
University of Cyprus
Study Overview
Official Title:
The Role of a Wearables-track Tele-exercising Program on Cognitive Function and Brain Oxygenation in Patients With Obstructive Sleep Apnea
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obstructive sleep apnea OSA contributes to a number of adverse health effects particularly on brain health Chronic sleep disturbances caused by OSA could adversely affect cognitive health Exercise is recommended as a non-pharmacological intervention for patients who are intolerant to continuous positive airway pressure CPAP and has been shown to have beneficial effects on brain health and cognitive function The aim of this protocol is to investigate the effects of a 12-week tele-exercise program on cognitive function and specific parameters of brain activity including brain metabolism and oxygenation in patients with OSA The project aims to demonstrate the multi-dimensional relationship between exercise cognition and brain oxygenationmetabolism Our local ethics committee has approved the study Our population sample group A OSA with cognitive impairment CI and tele-exercise group B OSA with CI and no tele-exercise group C OSA without CI and no tele-exercise will undergo assessment both before and after a 12-week tele-exercise intervention program This assessment will include a comprehensive battery of subjective and objective assessment tests Data will be analysed according to group stratification We hypothesize a beneficial effect of tele-exercise on sleep and cognitive parameters and we are confident that this study will raise awareness among healthcare professionals of the brain health benefits of exercise in patients with low compliance to CPAP treatment
Detailed Description:
Background Obstructive sleep apnea OSA is characterized by repetitive episodes of obstruction of the upper airway during sleep and leads to intermittent hypoxia sleep fragmentation hypercapnia and sympathetic hyperactivity which are associated with multiple adverse effects on health in particular with brain health Hyperarousability in OSA has a negative impact on sleep in the macro- and micro-architecture and sleep continuity both of which are important players in neurogenesis brain plasticity alertness and memory formation and consolidation Thus chronic sleep changes caused by OSA could negatively affect cognitive health Both sleep fragmentation and intermittent hypoxia interfere with brain structure and function increasing their vulnerability to neurodegenerative diseases The prevalence of OSA is increasing as it is conjoined with obesity and it tends to elude clinicians attention as in only 10 of the population the definitive diagnosis can be established Almost 80 of OSA patients report declining performance at work while 40 of dementia risk is attributable to modifiable risk factors such as physical inactivity
Exercise offers a wide variety of benefits for the general population as it improves the cardiopulmonary and metabolic profile In addition exercise is recommended as a low-cost easily administered and non-pharmacologic intervention with positive effect on brain health and cognitive function mainly by improving the sleep architecture by enhancing the neurovascular oxygenation process and cerebral oxygenation by reducing sympathetic overactivity and improving vascular function at rest and during exercise or mental stress Finally it has been shown that exercise can counteract the many aspects of decline in the brains environment such as the reduced blood flow and the lack of important factors ie brain-derived neurotrophic factor-BDNF that nurture brain neurons and encourage the growth and development of new neurons and synapses
Therefore long-term exercise providing the greatest and longest-lasting benefits eg increase cerebral neurovascular dynamics as assessed with functional Near-Infrared Spectroscopy fNIRS method and the intensity of exercise being related to cognitive functions such as improve memory after 12-week aerobic exercise and exercise with resistances The effectiveness of different physical activity programs has not been properly established and some studies suggest that supervised versus self-selected programs might have similar results In addition the types of exercise programs in patients with sleep disorders have been addressed in literature However it has been noted that compliance in supervised programs in particular those lasting several weeks can often be an important limitation of the studies Tele-exercising could be a key to overcome this important limitation however data on tele-exercising seems to be scarce
Purpose The main goal of the study is to explore the impact of a 12-week tele-exercising program on the cognitive profile as well as on specific parameters of brain functions brain metabolism and brain oxygenation in patients with obstructive sleep apnea thus highlighting the multidimensional relationship between physical exercise cognition and brain oxygenationmetabolism We will therefore apply a 12-week wearable-track tele-exercise intervention in patients with a Sleep Apnea Syndrome with and without cognitive impairment and compare the groups outcome on cognition and brain metabolism
The primary aim of this study is to investigate the extent to which tele-exercise improves cognitive functions in patients with OSA
For this aim we will compare the cognitive performance at baseline and at 12-weeks follow-up in 3 groups of patients
1 Patients with OSA without cognitive impairment
2 Patients with cognitive impairment assigned to a 12-week tele-exercising program
3 Patients with cognitive impairment not assigned to a tele-exercising intervention
For the screening of cognitive impairment and the evaluation of cognitive outcome the following cognitive tests will be performed
Attentionorientation memory verbal fluency language and visuospatial abilities at ADDENBROOKES COGNITIVE EXAMINATION - ACE-R
Outcome Changes between baseline and follow-up at ACE-R subdomains scores
Executive function and rote memory
Outcome Score at Trail Making Test A and B TMT
Verbal episodic memory based on subdomains of encoding process and immediate recall free and cued recall recognition and delayed recall
Outcome Score in a serial verbal learning task with control of encoding and recall according to the modified procedure of Grober and Buschke
Procedural memory
Outcome performance in a variation of the visual-motor skill-learning task the Mirror Tracing Task MTT
Working memory with subdomains the auditory information processing speed flexibility and working memory span
Outcome performance in the Modified Paced Auditory Serial Addition Test PASAT and in a task for Transformed Auditory Span
The secondary aims of this study are
1 To investigate the extent to which tele-exercise has a positive impact on brain oxygenation and metabolism in patients with OSA
Outcome cerebral oxygenation according to fNIRS-based measure levels of oxy-hemoglobin HbO and deoxygenated-hemoglobin deoxy-Hb For this aim we will compare cerebral oxygenation values fNIRS- at baseline and following a 12-week follow-up in the above mentioned three groups of patients
2 Investigate the extent to which tele-exercise has a positive impact on sleep architecture in patients with OSA
For this aim we will compare polysomnography quantitative and qualitative parameters as well as scores in sleepwake questionnaires at baseline and at 12 weeks follow-up in the above mentioned three groups of patients
Outcomes Change in sleep architecture sleep staging features and respiratory features in PSG between baseline and 12-weeks follow up
Participants We will recruit patients with clinical suspicion of OSA from Sleep Outpatient clinics at the Nicosia General Hospital Cyprus to undergo in home-based polysomnography study with portable device 1 We will perform a screening cognitive test ACE-R to identify individuals with cognitive impairment Patients with OSA and cognitive impairment CI will be randomized to two groups with CI that will undergo the tele-exercise program TEp Group A N20 and with CI That will not undergo the TEp Group B N20 A third matched group Group C of OSA patients without cognitive impairment N20 will act as another control group and will undergo the tele-exercise program A sample size estimation based on previous studies showed that 20 patients per group would be sufficient to detect differences in our primary outcome Groups A and C will carry out a tele-exercise program form Unique Safe Tele-Exercise Project platform httpsustepgr on a 12-week duration All patients which will be enrolled in our study will receive non-CPAP treatment delayed therapy Α feasibility study will precede with 10 OSA patients Apnea-Hypopnea-Index AHI gt15 eventsh and similar characteristics for a 12-week period of tele-exercising so as to investigate and record data related to exercise adherence drop-out and compliance All patients group they will be recommendations for diet focused on body weight loss as percent of body fat where required and sleep position to improve their quality of life scale score
Data collected Study-related assessments include a standard lung function testing followed by the diffusing capacity of the lungs for carbon monoxide according to ATSERS guidelines b physical fitness tests 6-MWT meters handgrip strength test kg and 30s Sit-to-Stand repetitions so as to record and assess O2 consumption mLminkg and muscle strength kg c the perceptual ability and reaction time test ms d prior to physical fitness tests will answer questionnaires on quality and patterns of sleep PSQI shifting attention and for selective attention TMT A and Β Epworth Sleep Scale ESS Karolinska Sleepiness Scale KSS cognitive impairment OSA risk MoCA and work ability WAI scales scores and e assessments to record cerebral oxygenation-oxygenated μmolL and deoxygenated hemoglobin μmolL fNIRS during physical fitness tests reaction time and when answering the questionnaires All the above assessments will be performed at baseline and at follow-up in 3 months
Interventions program The 12-week TEp will be performed and supported by the uStep platform with each patient taking part in 3 training sessions per week with a 60-min duration period per training session There will be personalized training sessions a warm-up and warm-down 5-min respectively with the mobility exercises and respiratory exercises for upper and lower limbs b aerobic exercise 30-min with continuous outdoor walking intensity calculation according HRpeak during 6MWT and self-reported feeling of dyspnea and leg fatigue and c multi-joint strength exercises 20-min to improve the strength of upper and lower limbs intensity calculation according to muscle strength tests Participants of the tele-exercise program will use wearable-based tracking during intervention period to assessment the cardio-oxygenation
Exercise offers a wide variety of benefits for the general population as it improves the cardiopulmonary and metabolic profile In addition exercise is recommended as a low-cost easily administered and non-pharmacologic intervention with positive effect on brain health and cognitive function mainly by improving the sleep architecture by enhancing the neurovascular oxygenation process and cerebral oxygenation by reducing sympathetic overactivity and improving vascular function at rest and during exercise or mental stress Finally it has been shown that exercise can counteract the many aspects of decline in the brains environment such as the reduced blood flow and the lack of important factors ie brain-derived neurotrophic factor-BDNF that nurture brain neurons and encourage the growth and development of new neurons and synapses
Therefore long-term exercise providing the greatest and longest-lasting benefits eg increase cerebral neurovascular dynamics as assessed with functional Near-Infrared Spectroscopy fNIRS method and the intensity of exercise being related to cognitive functions such as improve memory after 12-week aerobic exercise and exercise with resistances The effectiveness of different physical activity programs has not been properly established and some studies suggest that supervised versus self-selected programs might have similar results In addition the types of exercise programs in patients with sleep disorders have been addressed in literature However it has been noted that compliance in supervised programs in particular those lasting several weeks can often be an important limitation of the studies Tele-exercising could be a key to overcome this important limitation however data on tele-exercising seems to be scarce
Purpose The main goal of the study is to explore the impact of a 12-week tele-exercising program on the cognitive profile as well as on specific parameters of brain functions brain metabolism and brain oxygenation in patients with obstructive sleep apnea thus highlighting the multidimensional relationship between physical exercise cognition and brain oxygenationmetabolism We will therefore apply a 12-week wearable-track tele-exercise intervention in patients with a Sleep Apnea Syndrome with and without cognitive impairment and compare the groups outcome on cognition and brain metabolism
The primary aim of this study is to investigate the extent to which tele-exercise improves cognitive functions in patients with OSA
For this aim we will compare the cognitive performance at baseline and at 12-weeks follow-up in 3 groups of patients
1 Patients with OSA without cognitive impairment
2 Patients with cognitive impairment assigned to a 12-week tele-exercising program
3 Patients with cognitive impairment not assigned to a tele-exercising intervention
For the screening of cognitive impairment and the evaluation of cognitive outcome the following cognitive tests will be performed
Attentionorientation memory verbal fluency language and visuospatial abilities at ADDENBROOKES COGNITIVE EXAMINATION - ACE-R
Outcome Changes between baseline and follow-up at ACE-R subdomains scores
Executive function and rote memory
Outcome Score at Trail Making Test A and B TMT
Verbal episodic memory based on subdomains of encoding process and immediate recall free and cued recall recognition and delayed recall
Outcome Score in a serial verbal learning task with control of encoding and recall according to the modified procedure of Grober and Buschke
Procedural memory
Outcome performance in a variation of the visual-motor skill-learning task the Mirror Tracing Task MTT
Working memory with subdomains the auditory information processing speed flexibility and working memory span
Outcome performance in the Modified Paced Auditory Serial Addition Test PASAT and in a task for Transformed Auditory Span
The secondary aims of this study are
1 To investigate the extent to which tele-exercise has a positive impact on brain oxygenation and metabolism in patients with OSA
Outcome cerebral oxygenation according to fNIRS-based measure levels of oxy-hemoglobin HbO and deoxygenated-hemoglobin deoxy-Hb For this aim we will compare cerebral oxygenation values fNIRS- at baseline and following a 12-week follow-up in the above mentioned three groups of patients
2 Investigate the extent to which tele-exercise has a positive impact on sleep architecture in patients with OSA
For this aim we will compare polysomnography quantitative and qualitative parameters as well as scores in sleepwake questionnaires at baseline and at 12 weeks follow-up in the above mentioned three groups of patients
Outcomes Change in sleep architecture sleep staging features and respiratory features in PSG between baseline and 12-weeks follow up
Participants We will recruit patients with clinical suspicion of OSA from Sleep Outpatient clinics at the Nicosia General Hospital Cyprus to undergo in home-based polysomnography study with portable device 1 We will perform a screening cognitive test ACE-R to identify individuals with cognitive impairment Patients with OSA and cognitive impairment CI will be randomized to two groups with CI that will undergo the tele-exercise program TEp Group A N20 and with CI That will not undergo the TEp Group B N20 A third matched group Group C of OSA patients without cognitive impairment N20 will act as another control group and will undergo the tele-exercise program A sample size estimation based on previous studies showed that 20 patients per group would be sufficient to detect differences in our primary outcome Groups A and C will carry out a tele-exercise program form Unique Safe Tele-Exercise Project platform httpsustepgr on a 12-week duration All patients which will be enrolled in our study will receive non-CPAP treatment delayed therapy Α feasibility study will precede with 10 OSA patients Apnea-Hypopnea-Index AHI gt15 eventsh and similar characteristics for a 12-week period of tele-exercising so as to investigate and record data related to exercise adherence drop-out and compliance All patients group they will be recommendations for diet focused on body weight loss as percent of body fat where required and sleep position to improve their quality of life scale score
Data collected Study-related assessments include a standard lung function testing followed by the diffusing capacity of the lungs for carbon monoxide according to ATSERS guidelines b physical fitness tests 6-MWT meters handgrip strength test kg and 30s Sit-to-Stand repetitions so as to record and assess O2 consumption mLminkg and muscle strength kg c the perceptual ability and reaction time test ms d prior to physical fitness tests will answer questionnaires on quality and patterns of sleep PSQI shifting attention and for selective attention TMT A and Β Epworth Sleep Scale ESS Karolinska Sleepiness Scale KSS cognitive impairment OSA risk MoCA and work ability WAI scales scores and e assessments to record cerebral oxygenation-oxygenated μmolL and deoxygenated hemoglobin μmolL fNIRS during physical fitness tests reaction time and when answering the questionnaires All the above assessments will be performed at baseline and at follow-up in 3 months
Interventions program The 12-week TEp will be performed and supported by the uStep platform with each patient taking part in 3 training sessions per week with a 60-min duration period per training session There will be personalized training sessions a warm-up and warm-down 5-min respectively with the mobility exercises and respiratory exercises for upper and lower limbs b aerobic exercise 30-min with continuous outdoor walking intensity calculation according HRpeak during 6MWT and self-reported feeling of dyspnea and leg fatigue and c multi-joint strength exercises 20-min to improve the strength of upper and lower limbs intensity calculation according to muscle strength tests Participants of the tele-exercise program will use wearable-based tracking during intervention period to assessment the cardio-oxygenation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 101034403 | OTHER_GRANT | None | None |