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Health effects of treating sleep apnoea with Continuous Positive Airway Pressure (CPAP) during weight loss in people with pre-diabetes, sleep apnoea and obesity.

Cardio-metabolic health effects of CPAP treatment for sleep apnoea during weight loss: A Randomised Controlled Pilot Trial

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000823370
Enrollment
17
Registered
2017-06-06
Start date
2018-03-07
Completion date
2019-06-12
Last updated
2024-11-11

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

Conditions

None listed

Brief summary

This study will investigate the health effects of using CPAP to treat sleep apnoea in conjunction with a weight loss program. We hypothesise that using CPAP to treat sleep apnoea in conjunction with a weight loss program, compared with a weight loss program alone for 3 months, will better improve glucose tolerance, insulin sensitivity, abdominal and total fat mass and cholesterol, central blood pressure and 24 hour blood glucose levels. These hypotheses will be tested in 2 groups of patients with OSA, pre-diabetes and obesity using a three month randomised controlled trial (RCT) design, followed by a 9 month optional weight maintenance follow up period. The first group will receive CPAP plus a Very Low Energy Diet (VLED) for 3 months. Participants assigned to this group will then be offered sleep apnoea support and weight maintenance support for 9 months. Participants assigned to the second group will receive a VLED alone for 3 months. They will then be offered a 3 month trial of CPAP with the option of continuing on CPAP by themselves. They will also be offered sleep apnoea support and weight maintenance support for 9 months. The primary outcome will be the difference in glucose tolerance between CPAP and non-CPAP treated groups at 3 months.

Interventions

Intervention: CPAP with a Weight Loss Program CPAP: Participants assigned to the intervention group will be provided with a CPAP machine that with automatically titrate a therapeutic pressure. Prior to commencing CPAP the participants will receive CPAP education and undergo a mask fitting with a CPAP therapist. Participants will be issued with a CPAP and mask to use all night during sleep at home for the three months of the trial. Participants will have 2 pre-arranged consultations (face-to-f

Intervention: CPAP with a Weight Loss Program CPAP: Participants assigned to the intervention group will be provided with a CPAP machine that with automatically titrate a therapeutic pressure. Prior to commencing CPAP the participants will receive CPAP education and undergo a mask fitting with a CPAP therapist. Participants will be issued with a CPAP and mask to use all night during sleep at home for the three months of the trial. Participants will have 2 pre-arranged consultations (face-to-face or by telephone) for approximately 20 minutes at 2 weeks and 1 month to assist with the initial use of CPAP. Participants can also request additional consultations (as required) with the CPAP therapist to assist with ongoing use of the CPAP device. Weight Loss and Maintenance Program: Participants in the intervention group will also receive support with a Weight Loss and Maintenance Program administered by the study dietitian. The patients will receive a lifestyle consultation by phone call from the dietitian at 1 and 2 week time points. Participants will also attend the Woolcock Institute to participate in individual face-to-face lifestyle consultations conducted by the dietitian running for 1-1.5 hours at 1 and 2 months. Participants will also be invited to participate in optional weight maintenance support from the three month time point until the 12 month time point. The weight maintenance support appointments will involve a phone call at 5 and 7 months and a face-to-face consultation at 9 and 12 months. Participants will be asked to document diet, exercise, and sleep habits daily at periods during the trial. They will also be asked to complete a 4-day food diary at 0, 5 and 12 months. 24-hr food recall will also be undertaken at 0 weeks, then at 1, 2, 3, 7 and 9 months to confirm dietary compliance. Dietary program during the weight maintenance phase: Total daily energy intakes will be prescribed according to participants’ energy requirements, as estimated using the Harris-Benedict equation with an appropriate activity factor (it is suggested all activity be underestimated to ensure a conservative approach) and 2000kJ/500calorie /day energy deficit to encourage weight loss. Four levels of daily energy will be used in this study (5,7, 9 or 11 MJ/day) and participants will be prescribed an energy level which is closest to their energy intakes as calculated above. Desired macronutrient distribution will comprise 45% daily energy intake from carbohydrate, 25% from protein, 30% from fat and <1% from alcohol. The diet will aim to be as low in GI as practical and achieved by replacing higher GI carbohydrates with lower GI carbohydrates. Exercise program during weight loss and weight maintenance phases: Participants will be provided a safe, tailored exercise prescription with consideration of existing comorbidities or musculoskeletal limitations. The frequency, intensity and volume of exercise will be tailored according to the following progressive targets based on the Australian Physical Activity Guidelines for the general population and the American College of Sports Medicine (ACSM) guidelines for clinically significant weight loss: 1. Commencing with: at least 150 minutes per week of moderate intensity activity, i.e. 30 minutes on most days (Australian Physical Activity Guidelines for the general population) 2. Increasing to: at least 250 minutes per week of moderate intensity cardio exercise, i.e. 45-60 minutes most days (ACSM guidelines for clinically significant weight loss) 3. Plus: at least 1 session per week of ~20-45 minutes strength training 4. Increasing to: 2 times per week. (48-72 hours recovery between strength training sessions) 5. Plus: flexibility Lifestyle counselling: Individual dietary counselling is necessary to identify current dietary patterns, recommend specific changes, and identify barriers and target behavioural change strategies to the individual successfully. Sessions will consist of a combination of diet and exercise reinforcement and will provide the opportunity to progress exercise prescriptions as well as monitor dietary compliance. Health coaching techniques will support behaviour change and techniques are based on the Health Coaching Australia techniques in which the study clinicians are trained. Written materials: Participants will be provided with written educational materials that outline their dietary and exercise prescription including the food amounts that constitute one serving and the carbohydrate options and safe/sustainable dietary and exercise recommendations to support weight loss and maintenance.

Sponsors

Woolcock Institute of Medical Research, University of Sydney
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Community dwelling adults aged 18-65 years 2. Waist circumference: females >88cm, males >102cm non-European: famales >80cm, males >90cm and/or BMI >=27kg/m2 3. Pre-diabetes defined per World Health Organisation as any of the following recent (<3 months) findings: a) impaired fasting glucose with BGL between 5.5 and 7.0 mmol/L; b) impaired glucose tolerance with BGL between 7.8 and 11.0 mmol/L after a formal 75g OGTT; c) HbA1C between 6 and 6.5% 4. Moderate-severe hypoxaemic OSA with AHI>=20/hr and ODI>=10/hr prior to VLED induced weight loss, based on recent (<12 months) polysomography

Exclusion criteria

1. Any known contraindications to VLED or exercise 2. Recent weight loss that in the opinion of the treating physician is clinically significant 3. Current or recent (<3months) treatment of OSA 4. Professional drivers who are sleepy 5. Recent (<6 month) history of fall-asleep car crashes or near miss accidents 6. Excessive sleepiness that in the opinion of the treating physician requires immediate CPAP treatment 7. Severe medical (including renal failure) or psychiatric co-morbidity 8. Unstable medical conditions (hypertension, cardiac) 9. Recent use of illicit drugs or alcohol dependence 10. Current (or recent <3 months) use of hypoglycaemic agents 11. Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded) 12. Respiratory failure including obesity hypoventilation syndrome (OHS) (OHS as diagnosed by physician, based on standard criteria including: BMI >30kg/m2, arterial PaCO2 >45 and evidence of prolonged periods of hypoventilation and hypoxemia during sleep)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026