Variable Dead Space Rebreathing Device to Treat Sleep Apnea

NCT03552133 | Completed DMC FDA Device

• 4 other identifiers: 2016-0475A538500SMPH/POP HEALTH SCI/POP HEALTH1R21HL137874-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to determine the feasibility of using a novel treatment for sleep apnea in which the patient's own exhaled CO2 is tightly controlled and used in a rebreathe system to reduce sleep disordered breathing.

Conditions

Sleep Apnea, Obstructive; Sleep Apnea, Central

Keywords

variable deadspace; rebreathe; hypercapnic side-effects

Outcome Measures

Primary Outcomes (2)

• Aim 1: Determine the effects of Smart CO2 Device on AHI

  To determine the effects of a novel, adjustable CO2 rebreathing device on the occurrence of sleep apnea (AHI) in patients with moderate to severe obstructive sleep apnea.

  three to six weeks

• Determine the effect of Smart C02 Device on Arousal Index

  To determine the effects of a novel, adjustable CO2 rebreathing device on the occurrence of sleep apnea (Arousal Index) in patients with moderate to severe obstructive sleep apnea.

  three to six weeks

Secondary Outcomes (2)

• Aim 2: Effect on Sleep state stability

  Three to six weeks

• Determine the effects of Smart CO2 device on Blood pressure (both systolic and diastolic measures)

  Three to six weeks

Study Arms (2)

Smart CO2

EXPERIMENTAL

Effects of rebreathe device over two sleep nights on sleep apnea, hypoxemia, sleep state, and blood pressure.

Device: Smart CO2

No intervention

NO INTERVENTION

Effects of control night, i.e. no intervention on sleep apnea, hypoxemia, sleep state, and blood pressure.

Interventions

Smart CO2 DEVICE

A lightweight, cylindrical reservoir attached to a face mask which monitors breathing breath-by-breath and automatically adjusts the level of dead space rebreathe volume so that CO2 will be increased and sleep apnea treated.

Smart CO2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old, inclusive
• Moderate to severe OSA (Apnea hypopnea index \[AHI\] \>15 events/hr of sleep)
• Newly diagnosed OSA, or have either refused to or have not tolerated PAP treatment, or are currently using Positive Airway Pressure (PAP) and are willing to hold it during the night of sleep study visits.
• Willing and able to provide consent to 5 laboratory visits with 4 full nights of sleep study.
• Self report of still having sleep apnea since the last sleep test (if diagnosis was greater than a year prior).

You may not qualify if:

• BMI \>45 kg/m2
• AHI\<15 events/hour on the first night of sleep testing in our research laboratory (Visit 2)
• Cigarette smoking of 1 pack per day or more within 6 months of screening;
• Diagnosed heart failure or coronary artery disease.
• Diagnosed cerebrovascular disease, Transient Ischemic Attack (TIA) or stroke.
• Diagnosed asthma or chronic obstructive pulmonary disease with significant airways obstruction (FEVI/Forced Vital Capacity \<65%)
• End-stage hepatic or renal disease
• Significant daytime sleepiness in subjects who have risky occupations or life-style (for example, working in the transportation industry, history of motor vehicle crash, occupation that requires vigilance for safety or performance)
• Pregnancy (assessed on urine test at V1 in females with childbearing potential)
• Clinically significant arrhythmia/dysrhythmias on the clinical diagnostic polysomnography (per medical record) or on research polysomnography conducted at V2
• Established diagnosis of neuromuscular disease (e.g., Parkinsonism, multiple sclerosis, syringomyelia, transverse myelitis, amyotrophic lateral sclerosis, poliomyelitis, Eaton-Lambert, Guillain-Barre, myasthenia gravis, myotonic dystrophy, mononeuritis multiplex, in the setting of polymyositis/dermatomyositis or severe cervical spine disease)
• Any current use of benzodiazepines, opioids, or barbiturates
• Any medical or psychiatric condition which in the opinion of the medical director interferes with the subject's ability to enroll or to continue in the study (once enrolled)
• Veteran, cared for in the VA system

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Wisconsin Madison

Madison, Wisconsin, 53726, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jerome A Dempsey, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One control study night vs. two intervention study nights (subject serves as own control).

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 11, 2018
• Study Start: August 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)