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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxygen | Active Comparator | oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | Nocturnal nasal oxygen during stay at 2048 m |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 second night at 2048 m) |
| Apnea/hypopnea index measured by polygraphy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konrad E Bloch, MD | University Hospital, Zürich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Pulmonary Division | Zurich | CH-8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34645842 | Derived | 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. | |
| 34305642 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001991 | Bronchitis |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| sham oxygen (room air) |
| Drug |
|
|
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 second night 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. | Approximately 8 hours (during the first night 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. | Approximately at 10 a.m. on the second day 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. | Approximately 72 hours (day 1 to 3 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. | Approximately 8 hours (during the second night at 2048 m) |
| 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. |
| 32568400 | 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |