Effect of Obstructive Sleep Apnea on Glucose Control and Cognitive Function

Not Applicable

Withdrawn

• Conditions: Cognitive Change
• Interventions: Behavioral: Lifestyle modification program

• Registration Number: NCT05108363
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-24
• Study Start: 2021-11-01
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-04
• Primary Completion: 2023-05-31
• Study Completion: 2023-11-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle modification program	Lifestyle modification program	Patients with obstructive sleep apnea and prediabetes will have lifestyle modification program for 12 months

Primary Outcome Measures

Name	Time	Method
Change of Montreal Cognitive Assessment (MoCA) score	12 months	Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.

Secondary Outcome Measures

Name	Time	Method
Change of apnea-hypopnea index	12 months

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong, Hong Kong, China