Prisma Org
Puno, Peru
NCT Number: NCT03927547
Overall objective: To understand the feasibility of performing a randomized trial using a simple, minimally-invasive postural therapy approach to improve sleep disordered breathing (SDB).
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Notify Me40 year–80 year
All sexes
Interventional
Not applicable
Puno, Peru
Specific Aims:
Primary outcomes, at 4 and 8 weeks:
Secondary outcomes
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The following exclusion criteria apply only for those undergoing spirometry for safety reasons. Participants with any one of these criteria, will be excluded from spirometry but can still participate in the rest of the screening phase:
Study participants randomized to the interventional arm will be instructed to sleep on inclined wedge mattress.
Other names: wedge mattress, postural therapy
Time frame: Baseline, 4 weeks, 8 weeks
The investigators will measure a change in Respiratory Disturbance Index (RDI) defined as an oxygen desaturation of at least 4 percent associated with autonomic signs of arousal. Specifically, autonomic arousals are defined as concurrent rises in heart rate and attenuation of arterial tonometry.
Normal < 5 percent 5 percent < Mild < 15 percent 15 percent < Moderate < 30 percent Severe > 30 percent
Time frame: Baseline, 4 weeks, 8 weeks
The investigators will measure mean oxyhemoglobin saturation (%SaO2) during sleep as assessed by WatchPAT home sleep study at baseline and week 8.
Time frame: 2, 4, 6 and 8 weeks
Adherence monitor will measure sleep over the set time points and tolerability is defined as a recorded time on the wedge for a minimum of 5 hours.
Time frame: Baseline, 8 weeks
Time frame: Baseline, 8 weeks
This will measure percentage (%) of HbA1c in the blood.
Time frame: Baseline, 8 weeks
The concentration of EPO in the sample is expressed in International Units per litre (U/L) and is determined by calibration against a reference standard.
Time frame: Baseline, 8 weeks
Plasma levels of SVEGF-1 (pg/mL)
Time frame: Baseline, 8 weeks
Units of measurement is mass units.
Time frame: Baseline, 8 weeks
Time frame: Baseline, 8 weeks
Time frame: Baseline, 8 weeks
Time frame: Baseline, 8 weeks
Time frame: Baseline, 8 weeks
Units of measurement pg/mL
Time frame: Baseline, 8 weeks
Time frame: Baseline, 8 weeks
Assessed by endothelial function using high-frequency ultrasound visualized brachial artery reactivity testing. Endothelial function is characterized by flow-mediated vasodilation of the brachial artery, which is measured by comparing the brachial artery diameter at rest to the diameter after increased forearm blood flow (reactive hyperemia).
Unit of measurement is mass units.
Johns Hopkins University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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