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Clinical Trials/ISRCTN16974764
ISRCTN16974764
Completed
未知

Effects of an exercise program and a lifestyle app on sleep parameters, body composition, physical fitness and neurocognitive function in overweight and obese patients (aged 18-50 years) diagnostic of mild sleep disorders of breathing

Horizon 2020 - European Union0 sites200 target enrollmentFebruary 9, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Horizon 2020 - European Union
Enrollment
200
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 9, 2023
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Horizon 2020 - European Union

Eligibility Criteria

Inclusion Criteria

  • 1\. Signed, informed, written consent
  • 2\. Age 18 \- 50 years
  • 3\. Verified mild to moderate sleep\-disordered\-breathing according to the current American Academy of Sleep Medicine and International Classification of Sleep Disorders criteria
  • 4\. The SDB level may range from habitual snoring to positional and mild obstructive sleep apnea, not fulfilling the criteria for continuous positive airway pressure therapy treatment
  • 5\. BMI \=25 kg/m2 (overweight or obese)
  • 6\. Inactive person (no participation in exercise programs at baseline)
  • 7\. Subjects willing to try lifestyle change, including an exercise program
  • 8\. Willingness to perform the study\-specific testing both at baseline and during follow\-up
  • 9\. Ability to read, follow the lifestyle program and answer the questionnaires in DMP, electronic sleep diary and objective daytime testing (via DMP and physical visits)

Exclusion Criteria

  • 1\. Severe OSA
  • 2\. Inability to perform an exercise
  • 3\. Regular use of hypnotic medications
  • 4\. Clinically verified dominant central sleep apnea
  • 5\. Known history of active malignant disease
  • 6\. Blindness or hearing loss
  • 7\. Unstable cardiometabolic disease
  • 8\. Unstable psychiatric disease
  • 9\. Ongoing alcohol or drug abuse
  • 10\. Other medical conditions which may interfere with the study protocol in the opinion of the investigator

Outcomes

Primary Outcomes

Not specified

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