Clinical trial NCT02150590: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: airway disease
bronchitis
emphysema
lung
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: Approximately 8 hours (during the first night at 2048 m)
measure: Apnea/hypopnea index measured by polysomnography
timeFrame: Approximately 8 hours (during the first night at 2048 m)
Secondary outcomes:
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: Approximately 8 hours (during the second night at 2048 m)
measure: Apnea/hypopnea index measured by polygraphy
timeFrame: Approximately 8 hours (during the second night at 2048 m)
measure: Subjective sleep quality visual analog scale score
timeFrame: Approximately 8 hours (during the first night at 2048 m)
measure: Psychomotor vigilance test reaction time
timeFrame: Approximately at 10 a.m. on the second day at 2048 m
measure: Severe hypoxemia
timeFrame: Approximately 72 hours (day 1 to 3 at 2048 m)
measure: Subjective sleep quality visual analog scale score
timeFrame: Approximately 8 hours (during the second night at 2048 m)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
affiliation: University Hospital, Zürich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
References:
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.
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.
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.