Estimating Apnea Phenotypes From Polysomnography: Oxygen

NCT01751971 | Completed Results

• 2 other identifiers: 2005P001296-O2PSGR01HL090897
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to employ advanced methods to estimate the individual factors contributing to sleep apnea from standard recordings made during routine clinical sleep studies. This study focuses on breathing control or "loop gain" as one of the factors contributing to sleep apnea. Increased levels of oxygen in the air is known to make breathing more stable by lowering "loop gain". Here, our goal is to use a new method capable of detecting a reduction in loop gain with oxygen. The investigators also aim to test whether a high loop gain measured at baseline/placebo predicts a greater improvement in sleep apnea with oxygen therapy.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea Index

  Apnea-hypopnea index (AHI) will be compared between oxygen and sham nights. Hypopneas are based on 30% reduction in airflow (no desaturation or arousal criteria). AHI data are exclusive to non-REM supine sleep. The results presented here are for the AHI at each intervention ("per intervention") regardless of the sequence (preferred clinicaltrials.gov format). Please note, however, that the a priori outcome measure was the reduction in AHI with oxygen as a percent of sham values, i.e. (AHI on sham - AHI on oxygen)/(AHI on sham) % (a comparison with greater statistical power), compared between patient subgroups (see Statistical Analysis section). Subgroups were defined a priori as higher (\>=0.7) versus lower loop gain (\<0.7), but tests were also performed in subgroups defined by "favorable" versus "unfavorable" pathophysiology.

  1 night

Secondary Outcomes (5)

• Frequency of EEG Arousals (Events Per Hour)

  1 night

• Overnight Change in Systolic Blood Pressure

  1 night

• Overnight Change in Diastolic Blood Pressure

  1 night

• Subjective Sleep Quality (Oxygen vs Sham)

  1 night

• Subjective Sleepiness/Alertness (Stanford Sleepiness Scale)

  1 night

Study Arms (2)

Inspired Oxygen First

ACTIVE COMPARATOR

Participants breathe air with additional inspired oxygen (40%) for 1 night during an overnight sleep study (15 L/min via venturi mask). 1 week later participants will crossover to Sham (sham comparator).

Drug: Inspired oxygen (40%); Other: Sham

Sham First

SHAM COMPARATOR

Participants breathe air without additional inspired oxygen for 1 night during sleep (15 L/min via Venturi mask). 1 week later participants will crossover to Inspire Oxygen (active intervention).

Drug: Inspired oxygen (40%); Other: Sham

Interventions

Inspired oxygen (40%) DRUG

Supplemental oxygen at 40% inspired via venturi mask (15 L/min). Equivalent to 5 L/min via nasal cannula.

Also known as: Supplemental oxygen

Inspired Oxygen First; Sham First

Sham OTHER

Medical air with 21% oxygen via venturi mask (15 L/min).

Also known as: Medical air

Inspired Oxygen First; Sham First

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apnea/hypopnea index \>20 events per hour
• Age 20-79 years

You may not qualify if:

• COPD with desaturation (resting SpO2\<96%)
• Use of respiratory stimulants or depressants
• Pregnancy

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• American Heart Association: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Sands SA, Edwards BA, Terrill PI, Butler JP, Owens RL, Taranto-Montemurro L, Azarbarzin A, Marques M, Hess LB, Smales ET, de Melo CM, White DP, Malhotra A, Wellman A. Identifying obstructive sleep apnoea patients responsive to supplemental oxygen therapy. Eur Respir J. 2018 Sep 27;52(3):1800674. doi: 10.1183/13993003.00674-2018. Print 2018 Sep.

  PMID: 30139771 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

salicylhydroxamic acid; Air

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Results Point of Contact

• Title: Scott Sands, PhD
• Organization: Brigham and Women's Hospital

sasands@bwh.harvard.edu

6172780911

Study Officials

• SCOTT A Sands, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not informed whether they were breathing supplemental inspired oxygen or sham (air) on the study night. Technicians and investigators performing the study were not masked in order to carefully ensure delivery of treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 18, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 20, 2018
• Results First Posted: January 8, 2018

Record last verified: 2018-03

Locations

US (1)