Effect of Obstructive Sleep Apnea on Glucose Control and Cognitive Function

Cognitive Change Clinical Trial

Official title:

Effect of Obstructive Sleep Apnea on Glucose Control and Cognitive Function - a Substudy of 'Continuous Glucose Monitoring as an Adjunct to Lifestyle Modification in Individuals With Impaired Glucose Tolerance: a Randomised Controlled Trial'

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05108363
• Other study ID #: CGM-OSA
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Lifestyle modification program
Participants will attend dietary consultation sessions weekly in the first 4 months during the intensive phase , and monthly in the subsequent 8 months in the maintenance phase of LMP either face-to-face or via telephone. Participants will be given an individualized menu plan aiming at achieving a varied balanced diet with an emphasis on fiber intake and moderate-carbohydrate, low-fat, low-glycemic index products in appropriate portions. The diet will aim for a calorie reduction of 10-20%, at least 10% body weight reduction or body mass index less than 23 kg/m2.Participants will see an exercise instructor a minimum of four times starting at the 2nd month. The exercise instructor will design a suitable exercise regime. Participants will first be advised to increase daily physical activities or to do moderate intensity aerobic exercise, with the goal of 30 minutes for 3 to 5 days a week.

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Montreal Cognitive Assessment (MoCA) score	Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.	12 months
Secondary	Change of apnea-hypopnea index		12 months