Continuous Positive Airway Pressure and Acetazolamide to Treat Sleep Apnea Syndrome Patients at Altitude

NCT00928655 | Completed Phase 4 DMC

• 1 other identifier: EK-1522A#1-4
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the effect of nasal continuous positive airway pressure in combination with acetazolamide as a treatment for sleep related breathing disturbances in patients with the obstructive sleep apnea syndrome living at low altitude during a sojourn at moderate altitude.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

apnea; sleep; altitude; hypoxia; treatment; CPAP

Outcome Measures

Primary Outcomes (1)

• sleep disordered breathing and oxygenation

  day 2 and 3 at altitude

Secondary Outcomes (1)

• sleep quality, vigilance, acute mountain sickness, blood pressure

  day 2 and 3 at altitude

Study Arms (2)

acetazolamide

EXPERIMENTAL

combination of acetazolamide and nocturnal continuous positive airway pressure ventilation

Drug: acetazolamide; Procedure: nocturnal continuous positive airway pressure

placebo capsules

PLACEBO COMPARATOR

combination of placebo and nocturnal continuous positive airway pressure ventilation

Procedure: nocturnal continuous positive airway pressure; Drug: placebo

Interventions

acetazolamide DRUG

acetazolamide 250mg 1/0/2

Also known as: Diamox (trade name)

acetazolamide

nocturnal continuous positive airway pressure PROCEDURE

continuous positive airway pressure

Also known as: placebo capsules

acetazolamide; placebo capsules

placebo DRUG

placebo capsules

Also known as: placebo capsules

placebo capsules

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obstructive sleep apnea syndrome, successfully on CPAP therapy
• Residence at low altitude (\< 800 m)
• Obstructive apnea/hypopnea index \>20/h and a complaint of excessive daytime sleepiness before introduction of CPAP therapy
• \> 15 oxygen desaturations/h (\> 3% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP

You may not qualify if:

• Sleep disorders other than OSA
• More than mild cardiovascular disease, unstable cardiovascular disease
• Any lung disease, pulmonary hypertension
• Chronic rhinitis
• Treatment with drugs that affect respiratory center drive (benzodiazepines or other sedatives or sleep inducing drugs, morphine or codeine derivates), stimulants (modafinil, methylphenidate, theophylline)
• Internal, neurologic or psychiatric disease that interfere with sleep quality
• Previous intolerance to moderate or low altitude (\< 2600 m)
• Exposure to altitudes \> 1500m for \> 1 day within the last 4 weeks before the study

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre

Zurich, CH-8091, Switzerland

Location

Related Publications (4)

• Latshang TD, Nussbaumer-Ochsner Y, Henn RM, Ulrich S, Lo Cascio CM, Ledergerber B, Kohler M, Bloch KE. Effect of acetazolamide and autoCPAP therapy on breathing disturbances among patients with obstructive sleep apnea syndrome who travel to altitude: a randomized controlled trial. JAMA. 2012 Dec 12;308(22):2390-8. doi: 10.1001/jama.2012.94847.

  PMID: 23232895 BACKGROUND

• Latshang TD, Bloch KE, Lynm C, Livingston EH. JAMA patient page. Traveling to high altitude when you have sleep apnea. JAMA. 2012 Dec 12;308(22):2418. doi: 10.1001/jama.2012.4097. No abstract available.

  PMID: 23232901 BACKGROUND

• Latshang TD, Bloch KE. How to treat patients with obstructive sleep apnea syndrome during an altitude sojourn. High Alt Med Biol. 2011 Winter;12(4):303-7. doi: 10.1089/ham.2011.1055.

  PMID: 22206552 BACKGROUND

• Stadelmann K, Latshang TD, Nussbaumer-Ochsner Y, Tarokh L, Ulrich S, Kohler M, Bloch KE, Achermann P. Impact of acetazolamide and CPAP on cortical activity in obstructive sleep apnea patients. PLoS One. 2014 Apr 7;9(4):e93931. doi: 10.1371/journal.pone.0093931. eCollection 2014.

  PMID: 24710341 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea; Hypoxia

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Konrad E Bloch, MD

  University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre, Zurich, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 26, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

CH (1)