An interventional study of Positive Airway Pressure and Nasal Dilator Strip in Hypertensive Disorder of Pregnancy and Sleep Apnea, Obstructive, sponsored by Dr John Kimoff. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Dr John Kimoff · Not applicable, Interventional, and Treatment
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 48 is close to the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →This is the only study on the registry with Dr John Kimoff as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Automated positive airway pressure titration then treatment with fixed PAP.
Device: Positive Airway Pressure
Nightly use of nasal dilator strip
Device: Nasal Dilator Strip
Auto-PAP titration followed by fixed PAP treatment
Also known as: PAP
Nightly use of nasal dilator strip
PAP Adherence
The proportion of subjects demonstrating \>4h/night CPAP use by objective; microprocessor monitoring
Time frame: Through study completion, 8 weeks post-partum
Subject recruitment rates
Percent recruitment of eligible subjects
Time frame: Through study completion, 8 weeks post-partum
Subject retention rates
Number of subjects completing the study protocol
Time frame: Through study completion, 8 weeks post-partum
Maternal 24 hour blood pressure
24 hour ambulatory blood pressure
Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
Maternal blood pressure
Standardized blood pressure measurements using "BPTru" device
Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
Arterial stiffness measured as carotid-femoral pulse wave velocity
Non-invasive measurement of arterial stiffness using applanation tonometry
Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
Epworth Sleepiness Score
Standard subjective sleepiness score
Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
Pittsburgh Sleep Quality Index
Subjective sleep quality index
Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
Restless leg syndrome questionnaire
International Restless Legs Study Group questionnaire
Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
Functional Outcomes of Sleep Questionnaire
Sleep-related quality of life questionnaire
Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
Plan to share: No
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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