Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Breathing and Sleep

NCT02150590 | Completed Phase 4

• 1 other identifier: 2013-0088V2A3B
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with chronic obstructive lung disease.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

airway disease; bronchitis; emphysema; lung

Outcome Measures

Primary Outcomes (2)

• Mean nocturnal oxygen saturation measured by pulse oximetry

  Difference in mean nocturnal oxygen saturation between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

  Approximately 8 hours (during the first night at 2048 m)

• Apnea/hypopnea index measured by polysomnography

  Difference in apnea/hypopnea index between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

  Approximately 8 hours (during the first night at 2048 m)

Secondary Outcomes (6)

• Mean nocturnal oxygen saturation measured by pulse oximetry

  Approximately 8 hours (during the second night at 2048 m)

• Apnea/hypopnea index measured by polygraphy

  Approximately 8 hours (during the second night at 2048 m)

• Subjective sleep quality visual analog scale score

  Approximately 8 hours (during the first night at 2048 m)

• Psychomotor vigilance test reaction time

  Approximately at 10 a.m. on the second day at 2048 m

• Severe hypoxemia

  Approximately 72 hours (day 1 to 3 at 2048 m)

Study Arms (2)

Oxygen

ACTIVE COMPARATOR

oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

Drug: Oxygen; Drug: sham oxygen (room air)

Sham oxygen

PLACEBO COMPARATOR

Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

Drug: Oxygen; Drug: sham oxygen (room air)

Interventions

Oxygen DRUG

Nocturnal nasal oxygen during stay at 2048 m

Oxygen; Sham oxygen

sham oxygen (room air) DRUG

Also known as: Nocturnal nasal room air during stay at 2048 m

Oxygen; Sham oxygen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
• residents at low altitude (\<800 m)

You may not qualify if:

• unstable condition, COPD exacerbation
• mild (GOLD 1) or very severe COPD (GOLD 4)
• requirement for oxygen therapy at low altitude residence
• hypoventilation
• pulmonary hypertension
• more than mild or unstable cardiovascular disease
• use of drugs that affect respiratory center drive
• internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day), inability to perform 6 min walk test.
• previous intolerance to moderate altitude (\<2600m).
• exposure to altitudes \>1500m for \>2 days within the last 4 weeks before the study.
• pregnant or nursing patients

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Pulmonary Division

Zurich, CH-8091, Switzerland

Location

Related Publications (3)

• Gutweniger S, Latshang TD, Aeschbacher SS, Huber F, Flueck D, Lichtblau M, Ulrich S, Hasler ED, Scheiwiller PM, Ulrich S, Bloch KE, Furian M. Effect of nocturnal oxygen therapy on exercise performance of COPD patients at 2048 m: data from a randomized clinical trial. Sci Rep. 2021 Oct 13;11(1):20355. doi: 10.1038/s41598-021-98395-w.

  PMID: 34645842 DERIVED

• Lichtblau M, Latshang TD, Aeschbacher SS, Huber F, Scheiwiller PM, Ulrich S, Schneider SR, Hasler ED, Furian M, Bloch KE, Saxer S, Ulrich S. Effect of Nocturnal Oxygen Therapy on Daytime Pulmonary Hemodynamics in Patients With Chronic Obstructive Pulmonary Disease Traveling to Altitude: A Randomized Controlled Trial. Front Physiol. 2021 Jul 7;12:689863. doi: 10.3389/fphys.2021.689863. eCollection 2021.

  PMID: 34305642 DERIVED

• Tan L, Latshang TD, Aeschbacher SS, Huber F, Flueck D, Lichtblau M, Ulrich S, Hasler ED, Scheiwiller PM, Ulrich S, Bloch KE, Furian M. Effect of Nocturnal Oxygen Therapy on Nocturnal Hypoxemia and Sleep Apnea Among Patients With Chronic Obstructive Pulmonary Disease Traveling to 2048 Meters: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e207940. doi: 10.1001/jamanetworkopen.2020.7940.

  PMID: 32568400 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis; Emphysema

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Konrad E Bloch, MD

  University Hospital, Zürich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2014
• First Posted: May 30, 2014
• Study Start: June 1, 2014
• Primary Completion: October 31, 2014
• Study Completion: October 31, 2014
• Last Updated: January 29, 2019

Record last verified: 2017-05

Locations

CH (1)