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Effect of Obstructive Sleep Apnea on Glucose Control and Cognitive Function

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Withdrawn

Conditions

Cognitive Change

Treatments

Behavioral: Lifestyle modification program

Study type

Interventional

Funder types

Other

Identifiers

NCT05108363
CGM-OSA

Details and patient eligibility

About

Obstructive sleep apnea (OSA) may contribute to altered cognitive function in patients suffering from severe OSA. And lifestyle modification program may improve the cognitive function after 6 months of therapy.

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • BMI ≥ 25kg/m2
  • impaired glucose tolerance which defined as plasma glucose at the range of 7.8 and 11 mmol/l 2 hours after 75g oral glucose solution intake,
  • willing to participate in lifestyle modification program
  • and capable of using continuous glucose monitoring (CGM) as judged by investigator

Exclusion criteria

  1. Lactating or pregnant,
  2. known diabetes, current or previous use of glucose lowering drug
  3. current participation in other weight loss or lifestyle interventions, or use of weight loss drugs,
  4. current use of steroids
  5. uncontrolled thyrotoxicosis
  6. allergy to medical grade adhesives
  7. known obstructive sleep apnea on continuous positive airway pressure therapy
  8. symptoms of cognitive deterioration (according to the Hong Kong Montreal Cognitive Assessment (HK-MoCA) at the score of <21)
  9. predominant central sleep apnea
  10. uncontrolled hypertension (blood pressure >140/90mmHg) or requiring more than two anti-hypertensive medication
  11. history of stroke or brain injury,
  12. unstable cardiovascular disease (e.g. recent unstable angina or myocardial infarction within the previous 6 months or severe left ventricular failure; neuromuscular disease affecting or potentially affecting respiratory muscles; moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake SaO2 <92%)
  13. psychiatric disease that limits the ability to give informed consent or complete the study
  14. Use of psychoactive medication.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Lifestyle modification program
Other group
Description:
Patients with obstructive sleep apnea and prediabetes will have lifestyle modification program for 12 months
Treatment:
Behavioral: Lifestyle modification program

Trial contacts and locations

1

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Central trial contact

Susanna SS Ng

Data sourced from clinicaltrials.gov

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