Respiratory Drive on Obstructive Apnea

NCT01961648 | Terminated DMC

• 1 other identifier: B2012:132
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

This study is being conducted to determine whether inhaling exhaled carbon dioxide is effective for the treatment of sleep apnea. A mild increase in this gas can stimulate the respiratory drive by 2-3 fold, which in turn can stimulate the upper airway dilator muscles and decrease the severity of obstructive sleep apnea by at least 50% in selected patients.

Conditions

Obstructive Sleep Apnea

Keywords

Apnea; Sleep Apnea Disorder; Respiratory chemical drive; CO2

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total Apnea-hypopnea index (AHI)

  We expect that at least half the patients will undergo \>50% reduction in their AHI relative to the control part of the study. The baseline apnea-hypopnea index will be established during the sham intervention, and will be compared to the AHI at the end of the CO2 rebreathing intervention.

  Eight to ten hours. Within the same study night, the AHI will be compared at baseline and at the end of the intervention period

Secondary Outcomes (1)

• Sleep quality as assessed by Total Sleep Time. Sleep Efficiency, and Arousal Index

  Eight to ten hours. Within the same study night, the sleep quality conventional measurements will be compared at baseline and at the end of the intervention period

Study Arms (2)

Dead space

ACTIVE COMPARATOR

Participant will sleep connected to a mask with added dead space half of the night

Device: Rebreathing bag; Device: Mask

room air

SHAM COMPARATOR

Participant will sleep connected to a mask open to rrom air, half of the night

Device: Sham rebreathing; Device: Mask

Interventions

Rebreathing bag DEVICE

Also known as: CO2 rebreathing, Dead space

Dead space

Sham rebreathing DEVICE

Also known as: Room air

room air

Mask DEVICE

Dead space; room air

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe OSA Apnea Hypopnea Index \> 20/hr.
• Minimum oxygen saturation by pulse oximetry (SpO2) during events \>70% throughout sleep during the clinical sleep study

You may not qualify if:

• Neuromuscular disease.
• Obesity-hypoventilation syndrome.
• Chronic obstructive pulmonary disease.
• Pregnancy.
• Significant comorbidities:
• Dialysis-dependant renal failure
• Severe asthma
• Congestive
• Heart failure
• Previous stroke
• Recent (within 3 months) myocardial infarction or Active coronary ischemia event.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (2)

Misericordia Medical Centre, Sleep Disorder Centre

Winnipeg, Manitoba, R3C 1A2, Canada

Location

Sleep Disorder Centre at Misericordia Health Centre

Winnipeg, Manitoba, R3C 1A2, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea

Interventions

Masks

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: October 11, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2015
• Last Updated: June 29, 2015

Record last verified: 2013-09

Locations

CA (2)