None listed
Conditions
Brief summary
To determine if treatment of OSA during pregnancy, with CPAP or positional therapy, leads to improvement in clinical outcomes, particularly gestational diabetes. Pregnant women with any OSA, will be eligible to participate in the randomised trial, and will be randomized into three groups to be treated with Continuous Positive Airway Pressure (CPAP), Positional therapy and usual care. The primary outcome for this study is the incident gestational diabetes mellitus on oral glucose tolerance test (OGTT) performed at or prior to 28 weeks gestation
Interventions
Participants with obstructive sleep apnoea will be allocated in randomly permuted blocks 1:1:1 to one of three groups
- Intervention 1 (CPAP) and usual care
- Intervention 2 (Positional therapy) and usual care
- Usual care alone
Participants will be allocated to use either CPAP or positional therapy after the results of their first diagnostic sleep study is known. In the CPAP group, initially participants will be commenced on auto-titrating CPAP (an auto-set) until a suitable fixed press
Participants with obstructive sleep apnoea will be allocated in randomly permuted blocks 1:1:1 to one of three groups - Intervention 1 (CPAP) and usual care - Intervention 2 (Positional therapy) and usual care - Usual care alone Participants will be allocated to use either CPAP or positional therapy after the results of their first diagnostic sleep study is known. In the CPAP group, initially participants will be commenced on auto-titrating CPAP (an auto-set) until a suitable fixed pressure is determined between 3-7 days after they start. The sleep technician will then change them to an appropriate fixed pressure, which will be the 90th percentile pressure derived from the auto-set machine. The fixed pressure range will be from 6-20cm water pressure. The positional therpy device to be used is the "Nightshift" Positional Device. The device is a sensor attached to a silicone neck strap. The NightShift device uses vibrotactile feedback to discourage supine sleep. Downloaded data will provide compliance information associated with changes in sleep position and snoring. The treatment will be administered an experienced CPAP therapist. Participants will be encouraged to use the treatment CPAP or positional therapy every night from when they are commenced on it, until when they deliver the baby. Adherence will be monitored through data downloads (device analytics) for both the CPAP and positional therapy groups when the participants are reviewed in the antenatal clinic. The participants will be commenced on the treatment in the hospital clinic, but will use it at home .
Sponsors
South West Sydney Local Health District
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 No maximum
Healthy volunteers
No
Inclusion criteria
1. Early pregnancy (less than 14 weeks from last menstrual period) 2. Increased risk defined as ONE OR MORE of: a. Body mass index greater than or equal to 35 kg/m2 b. Previous gestational diabetes mellitus (GDM) c. Previous personal history of pre-eclampsia (or in mother or sister) d. Underlying renal disease e. Maternal type 2 diabetes (pre-gestational) f. Symptoms of sleep-disordered breathing including snoring, witnessed apnoeas, mild excessive daytime sleepiness (which does not meet the criteria for severe excessive daytime sleepiness) or tiredness. AND g. Obstructive sleep apnoea diagnosed on in-lab polysomnography, based on the respiratory disturbance index (RDI) of greater than or equal to 5.
Exclusion criteria
1. Previous diagnosis of sleep disordered breathing on active treatment 2. Confirmed GDM or pre-eclampsia 3. Maternal type 1 diabetes 4. Multifoetal gestation 5. Known foetal chromosomal abnormality 6. Inability to provide informed consent 7. Severe EDS based on clinical assessment (eg including a fall asleep MVA or near miss, transient sleepiness while driving/at lights or needing to pull over due to sleepiness while driving, or transient sleepiness in any other dangerous situation ie cooking, carrying baby) or Epworth Sleepiness Scale of greater than 15.
Outcome results
None listed