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Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 4

Locations

Kyrgyzstan

Study Type

Interventional

Intervention

Dexamethasone

Placebo

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2
Living at low altitude (<800m)

Exclusion Criteria:

COPD exacerbation
severe COPD, GOLD grade 3 or 4
arterial oxygen saturation <92% at low altitude (<800 m)
Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea.
Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day).
pregnant or nursing patients

Sites / Locations

National Center of Cardiology and Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

Dexamethasone 4 mg capsules, twice per day, orally

Placebo capsules twice per day, orally

Outcomes

Primary Outcome Measures

Mean nocturnal oxygen saturation measured by pulse oximetry

Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

Secondary Outcome Measures

Oxygen desaturation index

Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group

Mean nocturnal oxygen saturation measured by pulse oximetry

Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

Apnea/hypopnea index

Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group

Apnea/hypopnea index

Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group

Oxygen desaturation index

Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group

Mean nocturnal oxygen saturation measured by pulse oximetry

Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

Oxygen desaturation index

Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group

Apnea/hypopnea index

Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group

Psychomotor vigilance test reaction time

Difference in reaction time during psychomotor vigilance test between dexamethasone and placebo group

Subjective sleepiness

Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group

Subjective sleepiness

Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group

Full Information

NCT ID

NCT02450994

First Posted

May 18, 2015

Last Updated

December 18, 2015

Sponsor

University of Zurich

Collaborators

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

1. Study Identification

Unique Protocol Identification Number

NCT02450994

Brief Title

Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude

Official Title

Dexamethasone for Prophylaxis of Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease (COPD) Travelling to Altitude

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

Collaborators

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing sleep related breathing disturbances in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.

Detailed Description

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of dexamethasone prophylaxis in sleep related breathing disturbances in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (700m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Dexamethasone 2x4mg/day (or placebo), will be administered before departure at 700 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 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, treatment, sleep

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone

Arm Type

Active Comparator

Arm Description

Dexamethasone 4 mg capsules, twice per day, orally

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo capsules twice per day, orally

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Mean nocturnal oxygen saturation measured by pulse oximetry

Description

Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

Time Frame

night 1 at 3200 m

Secondary Outcome Measure Information:

Title

Oxygen desaturation index

Description

Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group

Time Frame

night 1 at 3200 m

Title

Mean nocturnal oxygen saturation measured by pulse oximetry

Description

Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

Time Frame

night 2 at 3200 m

Title

Apnea/hypopnea index

Description

Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group

Time Frame

night 2 at 3200 m

Title

Apnea/hypopnea index

Description

Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group

Time Frame

night 1 at 3200 m

Title

Oxygen desaturation index

Description

Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group

Time Frame

night 2 at 3200 m

Title

Mean nocturnal oxygen saturation measured by pulse oximetry

Description

Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

Time Frame

night 1 at 700 m

Title

Oxygen desaturation index

Description

Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group

Time Frame

night 1 at 700 m

Title

Apnea/hypopnea index

Description

Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group

Time Frame

night 1 at 700 m

Title

Psychomotor vigilance test reaction time

Description

Difference in reaction time during psychomotor vigilance test between dexamethasone and placebo group

Time Frame

day 2 at 700 m

Title

Subjective sleepiness

Description

Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group

Time Frame

day 2 at 700 m

Title

Subjective sleepiness

Description

Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group

Time Frame

day 2 at 3200 m

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2 Living at low altitude (<800m) Exclusion Criteria: COPD exacerbation severe COPD, GOLD grade 3 or 4 arterial oxygen saturation <92% at low altitude (<800 m) Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea. Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day). 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

First Name & Middle Initial & Last Name & Degree

Talant M Sooronbaev, MD

Organizational Affiliation

National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Official's Role

Study Director

Facility Information:

Facility Name

National Center of Cardiology and Internal Medicine

City

Bishkek

ZIP/Postal Code

720040

Country

Kyrgyzstan

12. IPD Sharing Statement

Citations:

PubMed Identifier

30794302

Citation

Furian M, Lichtblau M, Aeschbacher SS, Estebesova B, Emilov B, Sheraliev U, Marazhapov NH, Mademilov M, Osmonov B, Bisang M, Ulrich S, Latshang TD, Ulrich S, Sooronbaev TM, Bloch KE. Effect of Dexamethasone on Nocturnal Oxygenation in Lowlanders With Chronic Obstructive Pulmonary Disease Traveling to 3100 Meters: A Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190067. doi: 10.1001/jamanetworkopen.2019.0067.

Results Reference

derived

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Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude

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