AzTrials
AzTrials

Hypertensive Disorder of PregnancyNCT03309826

Positive Airway Pressure Treatment of Obstructive Sleep-disordered Breathing in Hypertensive Disorders of Pregnancy

A study testing Positive Airway Pressure and Nasal Dilator Strip in people with Hypertensive Disorder of Pregnancy and Sleep Apnea, Obstructive, run by Dr John Kimoff at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to conduct a pilot randomized, controlled trial to evaluate the feasibility and obtain pilot outcome data for a subsequent definitive trial evaluating the effects of postitive airway pressure (PAP) treatment of obstructive sleep-disordered breathing (OSDB) on blood pressure control and… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Positive Airway Pressure and Nasal Dilator Strip
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteCanada
Study dates
16 Oct 2017to 31 Dec 2021
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 y with a singleton pregnancy, ≥ 12 weeks' gestation
  • diagnosis of hypertensive disorder of pregnancy, including pre-existing hypertension, gestational hypertension and pre-eclampsia, as defined by Canadian Hypertensive Disorders of Pregnancy Working Group Criteria (Magee et al; Best Practice and Research Clinical obstetrics \& Gynaecology. 2015;29(5):643-657)
  • presence of obstructive sleep-disordered breathing (OSDB) on a single night in-home complete (Level 2) polysomnogram defined by an apnea-hypopnea index (AHI) ≥ 5 events/h and/or the presence of inspiratory flow limitation on ≥ 30% of breaths.

Who cannot join

  • severe pre-eclampsia/eclampsia requiring urgent delivery
  • chronic kidney disease or other secondary cause of hypertension
  • known cardiac disease, transient ischemic attack/stroke
  • malignancy or other chronic medical or psychiatric condition
  • smoking, alcohol use, illicit drugs
  • current/recent treatment for sleep-disordered breathing
  • severe sleep-disordered breathing defined as an apnea-hypopnea index (AHI) ≥ 30/h with either severe sleepiness (Epworth sleepiness score ≥ 15) or hypoxemia (4% Oxygen Desaturation Index ≥30/h or arterial oxygen saturation (SpO2) <80% for >10% of Total Sleep Time)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: Effects of Positive Airway Pressure Treatment of Obstructive Sleep-disordered Breathing on Maternal and Fetal Outcomes in Hypertensive Disorders of Pregnancy: a Pilot Randomized Controlled Trial

The purpose of this study is to conduct a pilot randomized, controlled trial to evaluate the feasibility and obtain pilot outcome data for a subsequent definitive trial evaluating the effects of postitive airway pressure (PAP) treatment of obstructive sleep-disordered breathing (OSDB) on blood pressure control and maternal and fetal outcomes in hypertensive disorders of pregnancy. The primary aim of the pilot study is to assess feasibility measured as the rates of subject recruitment, adequate (>4h/night) PAP adherence (primary outcome measure) and protocol completion. Secondary aims will be to obtain preliminary data on the effects of PAP on maternal blood pressure, complications of hypertension, arterial stiffness and vascular biomarkers, course of labor and delivery and fetal outcomes including growth restriction, prematurity, and neonatal distress.

Being tested
Positive Airway Pressure, Nasal Dilator Strip
Keywords
gestational hypertension, pre-eclampsia, eclampsia, obstructive sleep apnea-hypopnea, positive airway pressure, polysomnography, blood pressure, arterial stiffness
Medical subject headings
Toxemia, Sleep Apnea, Obstructive, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive Airway PressureDevice

    Also called PAP

    Auto-PAP titration followed by fixed PAP treatment

  • Nasal Dilator StripDevice

    Nightly use of nasal dilator strip

Study groups in NCT03309826
Study groupRoleWhat they receive
PAP Treatment ArmExperimentalAutomated positive airway pressure titration then treatment with fixed PAP.
Receives: Device: Positive Airway Pressure
Nasal Dilator StripActive comparatorNightly use of nasal dilator strip
Receives: Device: Nasal Dilator Strip

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PAP Adherence

    The proportion of subjects demonstrating >4h/night CPAP use by objective; microprocessor monitoring

    Measured: Through study completion, 8 weeks post-partum

Secondary outcomes (9)

  1. Subject recruitment rates

    Percent recruitment of eligible subjects

    Measured: Through study completion, 8 weeks post-partum

  2. Subject retention rates

    Number of subjects completing the study protocol

    Measured: Through study completion, 8 weeks post-partum

  3. Maternal 24 hour blood pressure

    24 hour ambulatory blood pressure

    Measured: Baseline, approximately one week prior to delivery and 8 weeks post-partum

  4. Maternal blood pressure

    Standardized blood pressure measurements using "BPTru" device

    Measured: Baseline, approximately one week prior to delivery and 8 weeks post-partum

  5. Arterial stiffness measured as carotid-femoral pulse wave velocity

    Non-invasive measurement of arterial stiffness using applanation tonometry

    Measured: Baseline, approximately one week prior to delivery and 8 weeks post-partum

  6. Epworth Sleepiness Score

    Standard subjective sleepiness score

    Measured: Baseline, approximately one week prior to delivery and 8 weeks post-partum

  7. Pittsburgh Sleep Quality Index

    Subjective sleep quality index

    Measured: Baseline, approximately one week prior to delivery and 8 weeks post-partum

  8. Restless leg syndrome questionnaire

    International Restless Legs Study Group questionnaire

    Measured: Baseline, approximately one week prior to delivery and 8 weeks post-partum

  9. Functional Outcomes of Sleep Questionnaire

    Sleep-related quality of life questionnaire

    Measured: Baseline, approximately one week prior to delivery and 8 weeks post-partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2017
  2. Study start16 Oct 2017
  3. Primary completion30 Jul 2021
  4. Study completion31 Dec 2021

Resources

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03309826
Sponsor's protocol ID
2018-2856
Status last verified
Oct 2023
First submitted
25 Sep 2017
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smocot J, Huynh N, Panyarath P, Kimoff RJ, Meltzer S, Drouin-Gagne L, Newbold R, Hebert C, Benedetti A, Arcache JP, Morency AM, Garfield N, Rey E, Pamidi S. Patterns of adherence to continuous positive airway pressure and mandibular advancement splints in pregnant individuals with sleep-disordered breathing. Sleep Breath. 2025 Apr 4;29(2):148. doi: 10.1007/s11325-025-03284-5.

    PubMed 40183988

  • Panyarath P, Goldscher N, Pamidi S, Daskalopoulou SS, Gagnon R, Dayan N, Raiche K, Olha A, Geater SL, Benedetti A, Kimoff RJ. Positive Airway Pressure Treatment of Obstructive Sleep Apnea-Hypopnea in Hypertensive Disorders of Pregnancy: A Pilot Randomized Proof-of-Concept Clinical Trial. Ann Am Thorac Soc. 2024 May;21(5):803-813. doi: 10.1513/AnnalsATS.202310-863OC.

    PubMed 38252423

Questions about this trial

What is this clinical trial studying?

A study testing Positive Airway Pressure and Nasal Dilator Strip in people with Hypertensive Disorder of Pregnancy and Sleep Apnea, Obstructive, run by Dr John Kimoff 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 3 inclusion and 7 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 23 Oct 2023. 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?

PAP Adherence (time frame: Through study completion, 8 weeks post-partum). 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 NCT03309826, which also lists 2 linked publications.

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 23 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in