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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

airway disease, bronchitis, emphysema, lung

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).

Gutweniger S, Latshang TD, Aeschbacher SS, Huber F, Flueck D, Lichtblau M, Ulrich S, Hasler ED, Scheiwiller PM, Ulrich S, Bloch KE, Furian M.

2021-10-136 citations

10.1038/s41598-021-98395-w

Effect of Nocturnal Oxygen Therapy on Daytime Pulmonary Hemodynamics in Patients With Chronic Obstructive Pulmonary Disease Traveling to Altitude: A Randomized Controlled Trial

Mona Lichtblau, Tsogyal D. Latshang, Sayaka S. Aeschbacher, Fabienne Huber, Philipp M. Scheiwiller et al. (14 authors)

Frontiers in Physiology2021-07-075 citations

10.3389/fphys.2021.689863

Effect of nocturnal oxygen therapy on next-day exercise performance of COPD patients at 2048m. Data from a RCT

S. Gutweniger, Tsogyal D. Latshang, Sayaka S. Aeschbacher, Fabienne Huber, Deborah Flueck et al. (12 authors)

2020-09-07

10.1183/13993003.congress-2020.1931

Effect of Nocturnal Oxygen Therapy on Nocturnal Hypoxemia and Sleep Apnea Among Patients With Chronic Obstructive Pulmonary Disease Traveling to 2048 Meters

Lu Tan, Tsogyal D. Latshang, Sayaka S. Aeschbacher, Fabienne Huber, Deborah Flueck et al. (12 authors)

JAMA Network Open2020-06-2228 citations

10.1001/jamanetworkopen.2020.7940

Interventions

DRUGOxygen

Nocturnal nasal oxygen during stay at 2048 m

DRUGsham oxygen (room air)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Mean nocturnal oxygen saturation measured by pulse oximetry	Approximately 8 hours (during the first night at 2048 m)	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	Approximately 8 hours (during the first night at 2048 m)	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

Measure	Time frame	Description
Subjective sleep quality visual analog scale score	Approximately 8 hours (during the first night at 2048 m)	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.
Mean nocturnal oxygen saturation measured by pulse oximetry	Approximately 8 hours (during the second night at 2048 m)	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.
Severe hypoxemia	Approximately 72 hours (day 1 to 3 at 2048 m)	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.
Psychomotor vigilance test reaction time	Approximately at 10 a.m. on the second day at 2048 m	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.
Apnea/hypopnea index measured by polygraphy	Approximately 8 hours (during the second night at 2048 m)	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.

Countries

Switzerland

Outcome results

None listed