Sleep Disordered BreathingNCT00757718
Sleep Disordered Breathing and Gestational Hypertension
A study testing CPAP and Oral Appliance in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative estimates, 4% of the adult female population has SDB. SDB is a recognized cause of hypertension and treating SDB can improve blood pressure control in people with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Gestational Hypertension
- What is being tested?
- CPAP and Oral Appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Jul 2009
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with singleton pregnancies who have the diagnosis of gestational hypertension.
Who cannot join
- Inability to comply with study parameters
- Delivery expected within 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative estimates, 4% of the adult female population has SDB. SDB is a recognized cause of hypertension and treating SDB can improve blood pressure control in people with hypertension. More recently, research efforts have looked at SDB as a possible cause of pregnancy induced hypertension (PIH), a condition which complicates 10% of pregnancies. Traditionally, the best way to assess SDB required patients to spend a night sleeping in the Sleep Laboratory. This is inconvenient and for pregnant women often impossible to arrange, considering the short time frame that exists between time of PIH diagnosis and eventual delivery. Researchers at the University of Saskatchewan are now looking at whether an adequate sleep assessment can be performed at the bedside - either in a patient's home or on the hospital ward. The researchers will also look at different treatment options for sleep apnea, to see if these can improve blood pressure control in this patient population, and delay the need for early delivery. The information from this study may result in a detailed sleep assessment becoming part of the complete assessment of women with PIH. There is an association between sleep disordered breathing (SDB) and gestational hypertension (GHTN). Treatment for the SDB may represent an effective addition to the management of the cardiovascular and metabolic perturbations of GHTN We plan to assess women whether treating SDB with one of two methods will improve the management of GHTN. We will also assess if one method is more effective than the other.
- Conditions
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Gestational Hypertension, Preeclampsia
- Being tested
- CPAP, Oral Appliance
- Keywords
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Gestational Hypertension, Preeclampsia
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called Respironics M Series Autoset CPAP, Somnoguard AP oral apliance, Breathe Right Nasal Srip
One half of the subjects will be randomly assigned to wear continuous a positive airway pressure device on the second night of the study. Portable polysomnography will be repeated for this night and morning bloodwork for inflammatory markers will be repeated.
Oral ApplianceDevice
Also called Somnoguard AP, Breathe Right nasal strip
Half of the subjects will be assigned to wear an oral appliance and nasal strip on the second night of the study. Repeat portable polysomnography will be performed and morning bloodwork will again be drawn for inflammatory markers.
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Active comparator | Subjects will have repeat polysomnography on the second night, while wearing a continuous positive airway pressure (CPAP) device. Morning bloodwork will be drawn for inflammatory mediators. Receives: Device: CPAP |
| Oral appliance | Experimental | Subjects will have repeat polysomnography on the second night, while wearing an oral appliance, as well as a Breathe-Right nasal strip. Morning bloodwork will be drawn for inflammatory mediators. Receives: Device: Oral Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the two treatment arms at treating sleep disordered breathing.
Measured: single night
Secondary outcomes (2)
Effectiveness of the treatment arms at improving metabolic perturbations of GHTN.
Measured: single night
Acceptability of therapy
Measured: single night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Investigators
- John K Reid, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757718
- Sponsor's protocol ID
- Bio: 08-21
- Status last verified
- Sep 2009
- First submitted
- 22 Sep 2008
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing and Gestational Hypertension
- ClinicalTrials.gov ID
- NCT00757718
- Acronym / sponsor ID
- Bio: 08-21
- Conditions
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Gestational Hypertension, Preeclampsia
- Keywords
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Gestational Hypertension, Preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Sep 2008 (estimated)
- 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.
Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative estimates, 4% of the adult female population has SDB. SDB is a recognized cause of hypertension and treating SDB can improve blood pressure control in people with hypertension. More recently, research efforts have looked at SDB as a possible cause of pregnancy induced hypertension (PIH), a condition which complicates 10% of pregnancies. Traditionally, the best way to assess SDB required patients to spend a night sleeping in the Sleep Laboratory. This is inconvenient and for pregnant women often impossible to arrange, considering the short time frame that exists between time of PIH diagnosis and eventual delivery. Researchers at the University of Saskatchewan are now looking at whether an adequate sleep assessment can be performed at the bedside - either in a patient's home or on the hospital ward. The researchers will also look at different treatment options for sleep apnea, to see if these can improve blood pressure control in this patient population, and delay the need for early delivery. The information from this study may result in a detailed sleep assessment becoming part of the complete assessment of women with PIH. There is an association between sleep disordered breathing (SDB) and gestational hypertension (GHTN). Treatment for the SDB may represent an effective addition to the management of the cardiovascular and metabolic perturbations of GHTN We plan to assess women whether treating SDB with one of two methods will improve the management of GHTN. We will also assess if one method is more effective than the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Active comparator | Device: CPAPSubjects will have repeat polysomnography on the second night, while wearing a continuous positive airway pressure (CPAP) device. Morning bloodwork will be drawn for inflammatory mediators. |
| Oral appliance | Experimental | Device: Oral ApplianceSubjects will have repeat polysomnography on the second night, while wearing an oral appliance, as well as a Breathe-Right nasal strip. Morning bloodwork will be drawn for inflammatory mediators. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with singleton pregnancies who have the diagnosis of gestational hypertension.
Key exclusion criteria (2 listed)
- Inability to comply with study parameters
- Delivery expected within 48 hours
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 |
|---|---|---|
| CPAPAlso: Respironics M Series Autoset CPAP, Somnoguard AP oral apliance, Breathe Right Nasal SripOne half of the subjects will be randomly assigned to wear continuous a positive airway pressure device on the second night of the study. Portable polysomnography will be repeated for this night and morning bloodwork for inflammatory markers will be repeated. | Device | CPAP treatment |
| Oral ApplianceAlso: Somnoguard AP, Breathe Right nasal stripHalf of the subjects will be assigned to wear an oral appliance and nasal strip on the second night of the study. Repeat portable polysomnography will be performed and morning bloodwork will again be drawn for inflammatory markers. | Device | Oral appliance |
Primary outcome
Effectiveness of the two treatment arms at treating sleep disordered breathing.
Time frame: single night
2 secondary outcomes
Effectiveness of the treatment arms at improving metabolic perturbations of GHTN.
Time frame: single night
Acceptability of therapy
Time frame: single night
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 9 Sep 2009.
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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.
John K Reid, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and Oral Appliance in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by University of Saskatchewan at 1 site in Canada.
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 1 inclusion and 2 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 9 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Effectiveness of the two treatment arms at treating sleep disordered breathing. (time frame: single night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2009.