Back to results

Effect of Obstructive Sleep Apnea on Glucose Control and Cognitive Function

Primary Purpose

Cognitive Change

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Lifestyle modification program

About this trial

This is an interventional treatment trial for Cognitive Change

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Prince of Wales Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lifestyle modification program

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of apnea-hypopnea index

Full Information

NCT ID

NCT05108363

First Posted

October 24, 2021

Last Updated

November 3, 2021

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT05108363

Brief Title

Effect of Obstructive Sleep Apnea on Glucose Control and Cognitive Function

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'

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 1, 2021 (Anticipated)

Primary Completion Date

May 31, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Change

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

And lifestyle modification program for 6 months of therapy

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle modification program

Arm Type

Other

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle modification program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of Montreal Cognitive Assessment (MoCA) score

Description

Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change of apnea-hypopnea index

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Susanna SS Ng

Phone

35052211

ssng@cuhk.edu.hk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanna Ng

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Prince of Wales Hospital

City

Hong Kong

State/Province

Hong Kong

Country

China

12. IPD Sharing Statement

Learn more about this trial

Effect of Obstructive Sleep Apnea on Glucose Control and Cognitive Function

We'll reach out to this number within 24 hrs