Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program
Primary Purpose
Obstructive Sleep Apnea
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Remotely-supervised rehabilitation program
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Remotely-supervised rehabilitation program, Apnea-Hypopnea Index, Telemonitoring, Telecoaching, Telerehabilitation, CPAP
Eligibility Criteria
Inclusion Criteria:
- signed informed consent
- newly diagnosed obstructive sleep apnea
- Apnea-Hypopnea Index greater than 15 episodes/hour
- indicated for CPAP therapy
Exclusion Criteria:
- severe pulmonary hypertension
- severe heart valve disease
- COPD III or IV
- central sleep apnea
- chronic corticosteroid therapy
- long-term oxygen therapy
- heart failure
- left ventricular ejection fraction lower than 40 %
- NYHA III or IV
- cerebrovascular disease
- psychiatric disease
- another type of obstructive sleep apnea treatment
- acute coronary syndrome in anamnesis
Sites / Locations
- University Hospital BrnoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Participants will undergo 12-week comprehensive remotely-supervised rehabilitation program along with individually titrated CPAP therapy.
Participants will undergo individually titrated CPAP therapy.
Outcomes
Primary Outcome Measures
Change from Baseline in Apnea-Hypopnea Index at Week 12
Measure will be taken from Polysomnography. Index shows number of apneic or hypopneic periods with duration at least 5 seconds in one hour. Higher Index means worse outcome.
Change from Baseline in Epworth Sleepiness Scale Score at Week 12
ESS Score is validated, self-reported instrument of patient's perception of obstructive sleep apnea. Possible scores range is from 0 to 24 points. Higher score means worse outcome.
Change from Baseline in SF-36 Questionnaire Score at Week 12
SF-36 Score is validated, self-reported instrument of patient's perception of health state and quality of life. Possible scores range is from 0 to 100 points. Higher score means better outcome.
Changes from Baseline in Body composition at Week 12
Measure will be taken from InBody 370.
Change from Baseline in 6 Minutes Walking Test at Week 12
6MWT will be evaluated on flat 30 metres long track marked with two cones. Longer distance means better outcome.
Change from Baseline in Maximal Inspiratory Pressure at Week 12
Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome.
Change from Baseline in Maximal Expiratory Pressure at Week 12
Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome.
Secondary Outcome Measures
Change from Baseline in Oxygen Desaturation Index at Week 12
Measure will be taken from Polysomnography. ODI means number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.
Change from Baseline in Neck/Waist/Hip circumferences at Week 12
All circumferences will be measured by tape measure.
Change from Baseline in Body Mass Index at Week 12
BMI will be calculated of participant's current weight and height.
Change from Baseline in Forced Vital Capacity at Week 12
Measure will be taken from Spirometry.
Change from Baseline in Forced Expiratory Volume in 1 Second at Week 12
Measure will be taken from Spirometry.
Full Information
NCT ID
NCT04759456
First Posted
February 15, 2021
Last Updated
January 10, 2023
Sponsor
Brno University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04759456
Brief Title
Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program
Official Title
Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brno University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the feasibility and effect of a 12-week remotely-supervised rehabilitation program in male patients between 25-65 years old with newly diagnosed obstructive sleep apnea with Apnea-Hypopnea Index greater than 15 episodes per hour indicated to CPAP therapy.
Detailed Description
The intervention group will undergo comprehensive remotely-supervised rehabilitaiton program in home conditions with teleconsultation (contains telecoaching, telemonitoring) via regular phone calls and e-mails at least 2 times a week. The intervention will include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated CPAP therapy.
The control group will undergo individually titrated CPAP therapy only. The participants in both groups will go through the following assessments before and after this study: polysomnography, spirometry, anthropometry and body composition examination, laboratory values examination, quality of life questionnaires, Epworth sleepiness scale, 6-min walking test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Remotely-supervised rehabilitation program, Apnea-Hypopnea Index, Telemonitoring, Telecoaching, Telerehabilitation, CPAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants will undergo 12-week comprehensive remotely-supervised rehabilitation program along with individually titrated CPAP therapy.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants will undergo individually titrated CPAP therapy.
Intervention Type
Other
Intervention Name(s)
Remotely-supervised rehabilitation program
Intervention Description
Include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated CPAP therapy
Primary Outcome Measure Information:
Title
Change from Baseline in Apnea-Hypopnea Index at Week 12
Description
Measure will be taken from Polysomnography. Index shows number of apneic or hypopneic periods with duration at least 5 seconds in one hour. Higher Index means worse outcome.
Time Frame
Baseline and Week 12
Title
Change from Baseline in Epworth Sleepiness Scale Score at Week 12
Description
ESS Score is validated, self-reported instrument of patient's perception of obstructive sleep apnea. Possible scores range is from 0 to 24 points. Higher score means worse outcome.
Time Frame
Baseline and Week 12
Title
Change from Baseline in SF-36 Questionnaire Score at Week 12
Description
SF-36 Score is validated, self-reported instrument of patient's perception of health state and quality of life. Possible scores range is from 0 to 100 points. Higher score means better outcome.
Time Frame
Baseline and Week 12
Title
Changes from Baseline in Body composition at Week 12
Description
Measure will be taken from InBody 370.
Time Frame
Baseline and Week 12
Title
Change from Baseline in 6 Minutes Walking Test at Week 12
Description
6MWT will be evaluated on flat 30 metres long track marked with two cones. Longer distance means better outcome.
Time Frame
Baseline and Week 12
Title
Change from Baseline in Maximal Inspiratory Pressure at Week 12
Description
Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome.
Time Frame
Baseline and Week 12
Title
Change from Baseline in Maximal Expiratory Pressure at Week 12
Description
Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in Oxygen Desaturation Index at Week 12
Description
Measure will be taken from Polysomnography. ODI means number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.
Time Frame
Baseline and Week 12
Title
Change from Baseline in Neck/Waist/Hip circumferences at Week 12
Description
All circumferences will be measured by tape measure.
Time Frame
Baseline and Week 12
Title
Change from Baseline in Body Mass Index at Week 12
Description
BMI will be calculated of participant's current weight and height.
Time Frame
Baseline and Week 12
Title
Change from Baseline in Forced Vital Capacity at Week 12
Description
Measure will be taken from Spirometry.
Time Frame
Baseline and Week 12
Title
Change from Baseline in Forced Expiratory Volume in 1 Second at Week 12
Description
Measure will be taken from Spirometry.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
signed informed consent
newly diagnosed obstructive sleep apnea
Apnea-Hypopnea Index greater than 15 episodes/hour
indicated for CPAP therapy
Exclusion Criteria:
severe pulmonary hypertension
severe heart valve disease
COPD III or IV
central sleep apnea
chronic corticosteroid therapy
long-term oxygen therapy
heart failure
left ventricular ejection fraction lower than 40 %
NYHA III or IV
cerebrovascular disease
psychiatric disease
another type of obstructive sleep apnea treatment
acute coronary syndrome in anamnesis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jakub Hnatiak, MSc.
Phone
+420 532233123
Email
Hnatiak.Jakub@fnbrno.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Ladislav Batalik, MSc., Ph.D.
Phone
+420 532232037
Email
Batalik.Ladislav@fnbrno.cz
Facility Information:
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program
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