Effect of Sleep Deprivation on Breathlessness and Exercise Capacity in COPD

NCT04997200 | Completed

• 1 other identifier: Version 1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized controlled cross-over trial designed to measure the effect of one night's sleep deprivation on exercise endurance, ventilation and breathlessness in outpatients with COPD.

Conditions

COPD

Keywords

Dyspnea; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Outcome Measures

Primary Outcomes (1)

• Change in breathlessness intensity (Borg CR10) between control and intervention at iso-time

  Change between conditions in breathlessness intensity using the Borg Category Ratio scale (Borg CR10), where 0 indicates no exertion and 10 indicates maximum exertion, at iso-time (defined as the time of the latest similar time point during both conditions (control and intervention) during a constant rate cycle cardiopulmonary exercise test (CPET).

  Measured during post-control and post-intervention exercise tests, spaced 7 days to 6 weeks apart

Secondary Outcomes (20)

• Change in breathlessness unpleasantness (Borg CR10) between control and intervention

  Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart

• Change in time to the limit of tolerance (tLIM) between control and intervention

  Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart

• Change in oxygen consumption between control and intervention (absolute)

  Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart

• Change in oxygen consumption between control and intervention (%pred)

  Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart

• Change in workload (W) between control and intervention

  Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart

Study Arms (2)

Intervention: One night's sleeplessness

EXPERIMENTAL

A night without sleep. No daytime sleeping the day before the test. Participants are observed by staff at the trial unit during the night before the test.

Behavioral: One night's sleeplessness

Control: One night's normal sleep

NO INTERVENTION

A normal night's sleep (at least six hours) in the patient's home.

Interventions

One night's sleeplessness BEHAVIORAL

A night without sleep. No daytime sleeping the day before the test. Participants are observed by staff at the trial unit during the night before the test.

Intervention: One night's sleeplessness

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• COPD diagnosed by physician in accordance with Global Initiative For Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD 2021), with a spirometric ratio of the forced expired volume in one second (FEV1) / forced vital capacity (FVC) \< 0.7 and a FEV1 \< 80% of predicted post bronchodilator at baseline.
• Self-reported average sleep time of six hours or longer during a normal night.
• No regular treatment with sleep medication or anxiolytics.
• Able to cycle
• Able to talk and write Swedish well enough to participate in the study procedures, as judged by the Investigator.

You may not qualify if:

• Resting peripheral oxygen saturation (SpO2) \< 92%
• Night shift worker
• Hospitalization or clinical instability during the last four weeks
• Treatment with supplementary oxygen at rest or during exercise
• Sleep disturbance, defined as a Pittsburgh Sleep Quality Index \>5 at baseline
• Contraindication to exercise testing in accordance with clinical practice guidelines (ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med 2003; 167:211-277)
• Expected survival shorter than six months as judged by the Investigator.

Sponsors & Collaborators

• Skane University Hospital: lead
• Blekinge County Council Hospital: collaborator

Study Sites (2)

Blekinge Tekniska Högskola (BTH)

Karlskrona, Blekinge County, 37179, Sweden

Location

Department of Clinical Physiology, Blekinge Hospital

Karlskrona, Blekinge County, SE-37185, Sweden

Location

Related Publications (8)

• O'Donnell DE, Banzett RB, Carrieri-Kohlman V, Casaburi R, Davenport PW, Gandevia SC, Gelb AF, Mahler DA, Webb KA. Pathophysiology of dyspnea in chronic obstructive pulmonary disease: a roundtable. Proc Am Thorac Soc. 2007 May;4(2):145-68. doi: 10.1513/pats.200611-159CC.

  PMID: 17494725 BACKGROUND

• Agusti A, Edwards LD, Celli B, Macnee W, Calverley PM, Mullerova H, Lomas DA, Wouters E, Bakke P, Rennard S, Crim C, Miller BE, Coxson HO, Yates JC, Tal-Singer R, Vestbo J; ECLIPSE Investigators. Characteristics, stability and outcomes of the 2011 GOLD COPD groups in the ECLIPSE cohort. Eur Respir J. 2013 Sep;42(3):636-46. doi: 10.1183/09031936.00195212. Epub 2013 Jun 13.

  PMID: 23766334 BACKGROUND

• Simon ST, Bausewein C, Schildmann E, Higginson IJ, Magnussen H, Scheve C, Ramsenthaler C. Episodic breathlessness in patients with advanced disease: a systematic review. J Pain Symptom Manage. 2013 Mar;45(3):561-78. doi: 10.1016/j.jpainsymman.2012.02.022. Epub 2012 Aug 24.

  PMID: 22921180 BACKGROUND

• Dharmarajan K, Swami S, Gou RY, Jones RN, Inouye SK. Pathway from Delirium to Death: Potential In-Hospital Mediators of Excess Mortality. J Am Geriatr Soc. 2017 May;65(5):1026-1033. doi: 10.1111/jgs.14743. Epub 2016 Dec 30.

  PMID: 28039852 BACKGROUND

• Rault C, Sangare A, Diaz V, Ragot S, Frat JP, Raux M, Similowski T, Robert R, Thille AW, Drouot X. Impact of Sleep Deprivation on Respiratory Motor Output and Endurance. A Physiological Study. Am J Respir Crit Care Med. 2020 Apr 15;201(8):976-983. doi: 10.1164/rccm.201904-0819OC.

  PMID: 31810378 BACKGROUND

• Chen R, Tian JW, Zhou LQ, Chen X, Yan HY, Zeng B, Zhang MS. The relationship between sleep quality and functional exercise capacity in COPD. Clin Respir J. 2016 Jul;10(4):477-85. doi: 10.1111/crj.12249. Epub 2015 Jan 15.

  PMID: 25515647 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24.

  PMID: 20335313 BACKGROUND

• Hedenstrom H, Malmberg P, Fridriksson HV. Reference values for lung function tests in men: regression equations with smoking variables. Ups J Med Sci. 1986;91(3):299-310. doi: 10.3109/03009738609178670.

  PMID: 3811032 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The analyst analyzing the data will be blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate professor

Model Details: Performed in randomized order on two separate days, at least seven days apart and no more than six weeks apart. * Intervention: A night without sleep. No daytime sleeping the day before the test. Participants are observed by staff at the trial unit during the night before the test. * Control: Normal night's sleep (at least six hours of sleep) in the patient's home. The participants wear an actigraph during 48 hours before the test to ensure adherence to the allocated condition (sleep deprivation or control).

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 9, 2021
• Study Start: September 13, 2021
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

SE (2)