Effect of Obstructive Sleep Apnea on Glucose Control and Cognitive Function

NCT05108363 | Withdrawn

• 1 other identifier: CGM-OSA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of apnea-hypopnea index

  12 months

Study Arms (1)

Lifestyle modification program

OTHER

Patients with obstructive sleep apnea and prediabetes will have lifestyle modification program for 12 months

Behavioral: Lifestyle modification program

Interventions

Lifestyle modification program BEHAVIORAL

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.

Lifestyle modification program

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lactating or pregnant,
• known diabetes, current or previous use of glucose lowering drug
• current participation in other weight loss or lifestyle interventions, or use of weight loss drugs,
• current use of steroids
• uncontrolled thyrotoxicosis
• allergy to medical grade adhesives
• known obstructive sleep apnea on continuous positive airway pressure therapy
• symptoms of cognitive deterioration (according to the Hong Kong Montreal Cognitive Assessment (HK-MoCA) at the score of \<21)
• predominant central sleep apnea
• uncontrolled hypertension (blood pressure \>140/90mmHg) or requiring more than two anti-hypertensive medication
• history of stroke or brain injury,
• 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%)
• psychiatric disease that limits the ability to give informed consent or complete the study
• Use of psychoactive medication.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

Study Officials

• Susanna Ng

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: And lifestyle modification program for 6 months of therapy

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 4, 2021
• Study Start: November 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: November 30, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CN (1)