Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Oxygen

sham oxygen (room air)

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring airway disease, bronchitis, emphysema, lung

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University Hospital Zurich, Pulmonary Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oxygen

Sham oxygen

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Apnea/hypopnea index measured by polygraphy

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.

Subjective sleep quality visual analog scale score

Difference in subjective sleep quality visual analog scale scores between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

Psychomotor vigilance test reaction time

Difference in subjective sleep quality between visual analog scale measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

Severe hypoxemia

Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the oxygen and sham oxygen treatment periods at 2028 m.

Subjective sleep quality visual analog scale score

Difference in subjective sleep quality visual analog scale scores between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

Full Information

NCT ID

NCT02150590

First Posted

May 18, 2014

Last Updated

January 26, 2019

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT02150590

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

June 1, 2014 (Actual)

Primary Completion Date

October 31, 2014 (Actual)

Study Completion Date

October 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Patients with moderate to severe chronic obstructive pulmonary disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypothesis that nocturnal breathing and sleep during nights spent at moderate altitude are improved by oxygen therapy via a nasal cannula compared to room air (sham oxygen). Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 nights each spent at moderate altitude (St. Moritz Salastrains, 2048 m) separated by a wash-out period of at least 2 weeks spent at low altitude (<800 m).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

airway disease, bronchitis, emphysema, lung

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxygen

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sham oxygen

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Oxygen

Intervention Description

Nocturnal nasal oxygen during stay at 2048 m

Intervention Type

Drug

Intervention Name(s)

sham oxygen (room air)

Other Intervention Name(s)

Nocturnal nasal room air during stay at 2048 m

Primary Outcome Measure Information:

Title

Mean nocturnal oxygen saturation measured by pulse oximetry

Description

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.

Time Frame

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

Title

Apnea/hypopnea index measured by polysomnography

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Mean nocturnal oxygen saturation measured by pulse oximetry

Description

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.

Time Frame

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

Title

Apnea/hypopnea index measured by polygraphy

Description

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.

Time Frame

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

Title

Subjective sleep quality visual analog scale score

Description

Difference in subjective sleep quality visual analog scale scores between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

Time Frame

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

Title

Psychomotor vigilance test reaction time

Description

Difference in subjective sleep quality between visual analog scale measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

Time Frame

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

Title

Severe hypoxemia

Description

Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the oxygen and sham oxygen treatment periods at 2028 m.

Time Frame

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

Title

Subjective sleep quality visual analog scale score

Description

Difference in subjective sleep quality visual analog scale scores between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: chronic obstructive pulmonary disease (COPD), GOLD grade 2-3 residents at low altitude (<800 m) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Konrad E Bloch, MD

Organizational Affiliation

University Hospital, Zürich

Official's Role

Study Chair

Facility Information:

Facility Name

University Hospital Zurich, Pulmonary Division

City

Zurich

ZIP/Postal Code

CH-8091

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

34645842

Citation

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.

Results Reference

derived

PubMed Identifier

34305642

Citation

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.

Results Reference

derived

PubMed Identifier

32568400

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs