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Effect of Obstructive Sleep Apnea on Glucose Control and Cognitive Function

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'

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05108363
Enrollment
0
Registered
2021-11-04
Start date
2021-11-01
Completion date
2023-11-30
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Change

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.

Interventions

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.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

And lifestyle modification program for 6 months of therapy

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of Montreal Cognitive Assessment (MoCA) score12 monthsScores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.

Secondary

MeasureTime frame
Change of apnea-hypopnea index12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026