Chronic Obstructive Pulmonary DiseaseNCT01870830
Nocturnal Breathing and Sleep in Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude
A study testing Altitude exposure in people with Chronic Obstructive Pulmonary Disease, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate altitude. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Altitude exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
- residents at low altitude (<800 m)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Pulmonary Division
Zurich, CH-8091
About this study
The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate altitude.
Read the detailed description
This randomized cross-over trial evaluates the hypothesis that patients with chronic obstructive pulmonary disease experience nocturnal hypoxemia, periodic breathing and sleep disturbances when staying at moderate altitude. Sleep studies and clinical evaluations will be performed during 2 days in Zurich (490 m, low altitude baseline) and during 2 days at Davos Clavadel (1650 m), and 2 days at Davos Jakobshorn (2590 m).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Altitude exposure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altitude exposureOther
Stay at different altitudes: 490, 1650, 2590 m
| Study group | Role | What they receive |
|---|---|---|
| A: low-intermediate-high altitude | Other | Altitude exposure sequence A, 490-1650-2590m Receives: Other: Altitude exposure |
| B: low-high-intermediate altitude | Other | Altitude exposure sequence B, 490-2590-1650m Receives: Other: Altitude exposure |
| C: intermediate-high-low altitude | Other | Altitude exposure sequence C, 1650-2590-490m Receives: Other: Altitude exposure |
| D: high-intermediate-low altitude | Other | Altitude exposure sequence D, 2590-1650-490m Receives: Other: Altitude exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean nocturnal oxygen saturation from baseline measured at 490 m
mean nocturnal oxygen saturation measured by pulse oximetry
Measured: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 2590 m
Change in apnea/hypopnea index from baseline measured at 490 m
apnea/hypopnea index measured by polysomnography
Measured: Change in apnea/hypopnea index from 490 m baseline during 2 days at 2590 m
Secondary outcomes (6)
Change in mean nocturnal oxygen saturation from baseline measured at 490 m
apnea/hypopnea measured by polysomnography
Measured: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 1650 m
Change in apnea/hypopnea index from baseline measured at 490 m
apnea/hypopnea index measured by polysomnography
Measured: Change in apnea/hypopnea index from 490 m baseline during stay at 1650 m
Change in subjective sleep quality from baseline measured at 490 m
Visual analog scale of sleep quality
Measured: Change in subjective sleep quality from 490 m during 2 days at 2590 m
Change in subjective sleep quality from baseline measured at 490 m
Visual analog scale of sleep quality
Measured: Change in subjective sleep quality from 490 m baseline during 2 days at 1650 m
Change in reaction time from baseline measured at 490 m
psychomotor vigilance test reaction time
Measured: Change in reaction time from 490 m baseline during 2 days at 2590 m
Change in reaction time from baseline measured at 490 m
Psychomotor vigilance test reaction time
Measured: Change in reaction time from 490 m baseline during 2 days at 1650 m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konrad E Bloch, MD, Study chair, University Hsopital Zurich, SwitzerlandTsogyal D Latshang, MD, Principal investigator, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870830
- Sponsor's protocol ID
- 2013-088B
- Status last verified
- May 2015
- First submitted
- 3 Jun 2013
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Latshang TD, Tardent RPM, Furian M, Flueck D, Segitz SD, Mueller-Mottet S, Kohler M, Ulrich S, Bloch KE. Sleep and breathing disturbances in patients with chronic obstructive pulmonary disease traveling to altitude: a randomized trial. Sleep. 2019 Jan 1;42(1). doi: 10.1093/sleep/zsy203.
PubMed 30517695
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nocturnal Breathing and Sleep in Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude
- ClinicalTrials.gov ID
- NCT01870830
- Acronym / sponsor ID
- 2013-088B
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate altitude.
Detailed description
This randomized cross-over trial evaluates the hypothesis that patients with chronic obstructive pulmonary disease experience nocturnal hypoxemia, periodic breathing and sleep disturbances when staying at moderate altitude. Sleep studies and clinical evaluations will be performed during 2 days in Zurich (490 m, low altitude baseline) and during 2 days at Davos Clavadel (1650 m), and 2 days at Davos Jakobshorn (2590 m).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: low-intermediate-high altitude | Other | Other: Altitude exposureAltitude exposure sequence A, 490-1650-2590m |
| B: low-high-intermediate altitude | Other | Other: Altitude exposureAltitude exposure sequence B, 490-2590-1650m |
| C: intermediate-high-low altitude | Other | Other: Altitude exposureAltitude exposure sequence C, 1650-2590-490m |
| D: high-intermediate-low altitude | Other | Other: Altitude exposureAltitude exposure sequence D, 2590-1650-490m |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
- residents at low altitude (<800 m)
Key exclusion criteria (11 listed)
- Unstable condition, COPD exacerbation
- Mild (GOLD 1) or very severe COPD (GOLD 4)
- requirement for oxygen therapy at low altitude residence
- hypoventilation
- pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Altitude exposureStay at different altitudes: 490, 1650, 2590 m | Other | A: low-intermediate-high altitude, B: low-high-intermediate altitude, C: intermediate-high-low altitude, D: high-intermediate-low altitude |
Primary outcome
Change in mean nocturnal oxygen saturation from baseline measured at 490 m
Time frame: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 2590 m
mean nocturnal oxygen saturation measured by pulse oximetry
Change in apnea/hypopnea index from baseline measured at 490 m
Time frame: Change in apnea/hypopnea index from 490 m baseline during 2 days at 2590 m
apnea/hypopnea index measured by polysomnography
6 secondary outcomes
Change in mean nocturnal oxygen saturation from baseline measured at 490 m
Time frame: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 1650 m
Change in apnea/hypopnea index from baseline measured at 490 m
Time frame: Change in apnea/hypopnea index from 490 m baseline during stay at 1650 m
Change in subjective sleep quality from baseline measured at 490 m
Time frame: Change in subjective sleep quality from 490 m during 2 days at 2590 m
Change in subjective sleep quality from baseline measured at 490 m
Time frame: Change in subjective sleep quality from 490 m baseline during 2 days at 1650 m
Change in reaction time from baseline measured at 490 m
Time frame: Change in reaction time from 490 m baseline during 2 days at 2590 m
Change in reaction time from baseline measured at 490 m
Time frame: Change in reaction time from 490 m baseline during 2 days at 1650 m
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Derived from this study: PubMed 30517695Latshang TD, Tardent RPM, Furian M, Flueck D, Segitz SD, Mueller-Mottet S, Kohler M, Ulrich S, Bloch KE. Sleep and breathing disturbances in patients with chronic obstructive pulmonary disease traveling to altitude: a randomized trial. Sleep. 2019 Jan 1;42(1). doi: 10.1093/sleep/zsy203.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konrad E Bloch, MD study chair
University Hsopital Zurich, Switzerland
Tsogyal D Latshang, MD principal investigator
University Hospital, Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altitude exposure in people with Chronic Obstructive Pulmonary Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean nocturnal oxygen saturation from baseline measured at 490 m (time frame: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 2590 m). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01870830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.