Sleep Apnea, ObstructiveNCT03356106
Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy
A study testing Continuous positive airway pressure (CPAP) in people with Sleep Apnea, Obstructive and Pre-Eclampsia, run by Ramathibodi Hospital at 3 sites in Thailand.
Trial summary
This is an open-label multicenter randomized-controlled trial in 3 tertiary care hospitals including Ramathibodi Hospital, Phramongkutklao Hospital and Rajavithi Hospital. The study involved screening of obstructive sleep apnea in high risk pregnancy during 1st and 2nd trimesters. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Sleep Apnea, Obstructive, Pre-Eclampsia, Hypertension, Pregnancy-Induced
- What is being tested?
- Continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 3 sitesThailand
- Study dates
- 16 Nov 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnant women age ≥ 18 years
- Pregnant women attending the antenatal care and intending to deliver at one of the study hospitals with gestational age < 16 weeks
- Thai nationality with ability to use Thai language proficiently both in spoken and written language.
- Have been diagnosed as high-risk pregnancy by Obstetricians by having any of the following conditions
- Chronic hypertension prior to pregnancy
- Hypertension during pregnancy before 20 weeks gestation.
Show all 12Show fewer
- Pre-eclampsia/gestational hypertension during recent pregnancy
- Obesity defined by pre-pregnancy body mass index (BMI) ≥ 27.5 kg/m2
- History of diabetes mellitus or gestational diabetes
- Having gestational diabetes or overt diabetes
- Presence of snoring (either as frequent snoring ≥3 times/week or loud snoring) prior to or occurring during pregnancy OR respiratory disturbance index, RDI ≥ 5 events/hour by type 2 sleep testing at either point of testing during early pregnancy (0-16 GA week) or late pregnancy (GA 24-28week ).
- Sign written informed consent
Who cannot join
- Subjects' unwillingness to participate in the study at any time of the study.
- Subject with significant medical conditions such as immunocompromised status, chronic infection (HIV infection, tuberculosis), chronic lung and cardiac conditions, chronic renal failure, thyroid disease, or neuromuscular disease.
- Subjects with extremely severe obstructive sleep apnea (RDI ≥30) or with significant O2 desaturation <80% during sleep that might have potential benefit from the CPAP treatment.
- Subject with known obstructive sleep apnea and currently on CPAP treatment
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Phramongkutklao Hospital
Bangkok, 10400
Rajavithi Hospital
Bangkok, 10400
Ramathibodi hospital
Bangkok, 10400
About this study
Official title: Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy: A Multi-center Randomized Controlled Trial
This is an open-label multicenter randomized-controlled trial in 3 tertiary care hospitals including Ramathibodi Hospital, Phramongkutklao Hospital and Rajavithi Hospital. The study involved screening of obstructive sleep apnea in high risk pregnancy during 1st and 2nd trimesters. Randomization to either continuous positive airway pressure (CPAP) or usual antenatal care (ANC) until delivery will be done. Efficacy of CPAP on pregnancy outcome will be analysed.
Read the detailed description
Screening for sleep disordered breathing (Respiratory disturbance index, RDI ≥ 5 events/hour) with type 2 sleep test will be performed in eligible subjects during early1st trimester (<16 weeks). Repeat sleep study will be done if the RDI in 1st trimester is less than 5. If the subjects meet the inclusion criteria without any of the exclusion criteria, randomization into either receiving CPAP treatment or usual ANC will be done. The pressure of CPAP machine is determined using autoCPAP machine algorithm at 90 percentile. Adjustment of CPAP machine is repeated at 24-28 week gestations. Subjects in both groups received standard usual care during ANC and outcomes were measured with similar case record forms.
- Being tested
- Continuous positive airway pressure (CPAP)
- Keywords
- Obstructive sleep apnea, Pre-Eclampsia
- Medical subject headings
- Sleep Apnea, Obstructive, Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP)Device
A non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | Nocturnal administration of continuous positive airway pressure treatment (CPAP) until delivery Receives: Device: Continuous positive airway pressure (CPAP) |
| Control | No intervention | Usual antenatal care for high risk pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of blood pressure
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Measured: During 24-28 weeks gestation
Measurement of blood pressure
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Measured: During 32-34 weeks gestation
Measurement of blood pressure
Difference of daytime mean blood pressure between 2 groups (mmHg)
Measured: During 24-28 weeks gestation
Measurement of blood pressure
Difference of daytime mean blood pressure between 2 groups(mmHg)
Measured: During 32-34 weeks gestation
Measurement of blood pressure
Difference of daytime mean blood pressure between 2 groups (mmHg)
Measured: During 18-20 weeks gestation
Measurement of blood pressure
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Measured: During 18-20 weeks gestation
Secondary outcomes (17)
24-hour ambulatory blood pressure monitoring
Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)
Measured: measured twice during 24-28 week gestation, and 32-34 week gestation
24-hour ambulatory blood pressure monitoring
Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)
Measured: measured twice during 32-34 week gestation
Incidence of pregnancy induced hypertension (composite outcome1)
Incidence of hypertensive disorder of pregnancy
Measured: During pregnancy until delivery
Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section (composite outcome2)
Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section
Measured: During pregnancy until delivery
Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death (composite outcome3)
Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death
Measured: During pregnancy until delivery
Fasting plasma glucose
Fasting plasma glucose (mg/dL)
Measured: during 24-28 weeks gestation
Fasting plasma glucose
Fasting plasma glucose (mg/dL)
Measured: during 32-34 weeks gestation
Oral glucose tolerance test (OGTT)
Oral Glucose Tolerance Test (OGTT) (mg/dL)
Measured: during 24-28 weeks gestation
Fetal ultrasound results
Fetal growth (grams)
Measured: During 24-28 weeks gestation
Fetal ultrasound results
Fetal growth (grams)
Measured: During 32-34 weeks gestation
Fetal ultrasound results
Uterine Doppler arterial blood flow
Measured: During 18-20 weeks gestation
Fetal ultrasound results
Uterine Doppler arterial blood flow
Measured: During 24-28 weeks gestation
Fetal ultrasound results
Uterine Doppler arterial blood flow
Measured: During 32-34 weeks gestation
Neonatal birthweight
Neonatal birthweight (grams)
Measured: at delivery
APGAR score
The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration). Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
Measured: at 1 minute and 5 minutes after birth
Neonatal length of stay in hospital
Neonatal length of hospital stay (days) after birth until the newborn is discharged from the hospital
Measured: Through study completion up to 24 weeks
Neonatal ICU admission rate
Neonatal ICU admission rate (%) after birth
Measured: Through study completion up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start16 Nov 2016
- Primary completion30 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Principal investigator, Visasiri Tantrakul, Ramathibodi Hospital
- Investigators
- Visasiri Tantrakul, MD, Principal investigator, Ramathibodi Hospital Sleep Disorder Center, Pulmonary and Care division, Department of Medicine, Ramatibodi Hospital, Mahidol University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356106
- Sponsor's protocol ID
- ID11-58-12
- Status last verified
- Dec 2021
- First submitted
- 26 Sep 2017
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For the first five years after the trial is concluded (upon acceptance of the primary manuscript for publication) the data will remain accessible only to the trial investigators for the purpose of additional analyses and publications. Thereafter other interested researchers may request in writing to the Steering Committee access to the data for the purpose of meta-analyses, with approval of a protocol and signed data access agreement via contacting the principle investigators of Division of Sleep Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
Publications
Tantrakul V, Ingsathit A, Liamsombut S, Rattanasiri S, Kittivoravitkul P, Imsom-Somboon N, Lertpongpiroon S, Jantarasaengaram S, Somchit W, Suwansathit W, Pengjam J, Siriyotha S, Panburana P, Guilleminault C, Preutthipan A, Attia J, Thakkinstian A. Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial. Respir Res. 2023 Jun 27;24(1):171. doi: 10.1186/s12931-023-02445-y.
PubMed 37370135
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy: A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03356106
- Acronym / sponsor ID
- ID11-58-12
- Keywords
- Obstructive sleep apnea, Pre-Eclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label multicenter randomized-controlled trial in 3 tertiary care hospitals including Ramathibodi Hospital, Phramongkutklao Hospital and Rajavithi Hospital. The study involved screening of obstructive sleep apnea in high risk pregnancy during 1st and 2nd trimesters. Randomization to either continuous positive airway pressure (CPAP) or usual antenatal care (ANC) until delivery will be done. Efficacy of CPAP on pregnancy outcome will be analysed.
Detailed description
Screening for sleep disordered breathing (Respiratory disturbance index, RDI ≥ 5 events/hour) with type 2 sleep test will be performed in eligible subjects during early1st trimester (<16 weeks). Repeat sleep study will be done if the RDI in 1st trimester is less than 5. If the subjects meet the inclusion criteria without any of the exclusion criteria, randomization into either receiving CPAP treatment or usual ANC will be done. The pressure of CPAP machine is determined using autoCPAP machine algorithm at 90 percentile. Adjustment of CPAP machine is repeated at 24-28 week gestations. Subjects in both groups received standard usual care during ANC and outcomes were measured with similar case record forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: Continuous positive airway pressure (CPAP)Nocturnal administration of continuous positive airway pressure treatment (CPAP) until delivery |
| Control | No intervention | –Usual antenatal care for high risk pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Singleton pregnant women age ≥ 18 years
- Pregnant women attending the antenatal care and intending to deliver at one of the study hospitals with gestational age < 16 weeks
- Thai nationality with ability to use Thai language proficiently both in spoken and written language.
- Have been diagnosed as high-risk pregnancy by Obstetricians by having any of the following conditions
- Presence of snoring (either as frequent snoring ≥3 times/week or loud snoring) prior to or occurring during pregnancy OR respiratory disturbance index, RDI ≥ 5 events/hour by type 2 sleep testing at either point of testing during early pregnancy (0-16 GA week) or late pregnancy (GA 24-28week ).
Key exclusion criteria (4 listed)
- Subjects' unwillingness to participate in the study at any time of the study.
- Subject with significant medical conditions such as immunocompromised status, chronic infection (HIV infection, tuberculosis), chronic lung and cardiac conditions, chronic renal failure, thyroid disease, or neuromuscular disease.
- Subjects with extremely severe obstructive sleep apnea (RDI ≥30) or with significant O2 desaturation <80% during sleep that might have potential benefit from the CPAP treatment.
- Subject with known obstructive sleep apnea and currently on CPAP treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressure (CPAP)A non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep | Device | CPAP |
Primary outcome
Measurement of blood pressure
Time frame: During 24-28 weeks gestation
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Measurement of blood pressure
Time frame: During 32-34 weeks gestation
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Measurement of blood pressure
Time frame: During 24-28 weeks gestation
Difference of daytime mean blood pressure between 2 groups (mmHg)
Measurement of blood pressure
Time frame: During 32-34 weeks gestation
Difference of daytime mean blood pressure between 2 groups(mmHg)
Measurement of blood pressure
Time frame: During 18-20 weeks gestation
Difference of daytime mean blood pressure between 2 groups (mmHg)
Measurement of blood pressure
Time frame: During 18-20 weeks gestation
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
17 secondary outcomes
24-hour ambulatory blood pressure monitoring
Time frame: measured twice during 24-28 week gestation, and 32-34 week gestation
24-hour ambulatory blood pressure monitoring
Time frame: measured twice during 32-34 week gestation
Incidence of pregnancy induced hypertension (composite outcome1)
Time frame: During pregnancy until delivery
Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section (composite outcome2)
Time frame: During pregnancy until delivery
Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death (composite outcome3)
Time frame: During pregnancy until delivery
Fasting plasma glucose
Time frame: during 24-28 weeks gestation
Fasting plasma glucose
Time frame: during 32-34 weeks gestation
Oral glucose tolerance test (OGTT)
Time frame: during 24-28 weeks gestation
Fetal ultrasound results
Time frame: During 24-28 weeks gestation
Fetal ultrasound results
Time frame: During 32-34 weeks gestation
Fetal ultrasound results
Time frame: During 18-20 weeks gestation
Fetal ultrasound results
Time frame: During 24-28 weeks gestation
Fetal ultrasound results
Time frame: During 32-34 weeks gestation
Neonatal birthweight
Time frame: at delivery
APGAR score
Time frame: at 1 minute and 5 minutes after birth
Neonatal length of stay in hospital
Time frame: Through study completion up to 24 weeks
Neonatal ICU admission rate
Time frame: Through study completion up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Derived from this study: PubMed 37370135Tantrakul V, Ingsathit A, Liamsombut S, Rattanasiri S, Kittivoravitkul P, Imsom-Somboon N, Lertpongpiroon S, Jantarasaengaram S, Somchit W, Suwansathit W, Pengjam J, Siriyotha S, Panburana P, Guilleminault C, Preutthipan A, Attia J, Thakkinstian A. Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial. Respir Res. 2023 Jun 27;24(1):171. doi: 10.1186/s12931-023-02445-y.
- Individual participant dataSharing planned: No. For the first five years after the trial is concluded (upon acceptance of the primary manuscript for publication) the data will remain accessible only to the trial investigators for the purpose of additional analyses and publications. Thereafter other interested researchers may request in writing to the Steering Committee access to the data for the purpose of meta-analyses, with approval of a protocol and signed data access agreement via contacting the principle investigators of Division of Sleep Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Visasiri Tantrakul, MD principal investigator
Ramathibodi Hospital Sleep Disorder Center, Pulmonary and Care division, Department of Medicine, Ramatibodi Hospital, Mahidol University, Thailand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure (CPAP) in people with Sleep Apnea, Obstructive and Pre-Eclampsia, run by Ramathibodi Hospital at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of blood pressure (time frame: During 24-28 weeks gestation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03356106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.