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'

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.

Study Overview

• Status: Withdrawn
• Conditions: Cognitive Change
• Intervention / Treatment: Behavioral: Lifestyle modification program

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Lifestyle modification program; Patients with obstructive sleep apnea and prediabetes will have lifestyle modification program for 12 months

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Change of apnea-hypopnea index	12 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Susanna Ng, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2021
• Primary Completion (Estimated): May 31, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: October 24, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CGM-OSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No