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Sleep and Breathing in the General Population - Chemical Stimuli

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Wayne State University

Status and phase

Completed
Phase 4

Conditions

Sleep-disordered Breathing

Treatments

Drug: Zolpidem
Other: No Treatment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04720547
5R01HL130552-05 (U.S. NIH Grant/Contract)
1203010749

Details and patient eligibility

About

Central sleep apnea (CSA) is a common condition and its treatment remains elusive. The focus of this proposal is to identify the role of the physiologic path involving cortical arousals in CSA by decreasing arousal frequency using the pharmacological agent zolpidem. The goal is to identify the acute effects of administering zolpidem on sleep and respiratory outcomes, and subsequently, its effect on the severity of CSA and propensity to develop CSA. This study will shed light on the mechanisms underlying CSA that involve cortical arousals and will guide future therapeutic interventions for CSA.

Full description

The literature suggests that zolpidem may be effective in the treatment of central sleep apnea (CSA). However, evidence regarding the efficacy of zolpidem and the underlying mechanisms involved in its effect on CSA are not well-studied. Furthermore, respiratory-related arousals are hypothesized to contribute CSA symptoms and severity. The aim of the study is to determine the effect of decreasing respiratory-related arousals on the propensity to develop central apnea. The investigators hypothesize that administration of the nonbenzodiazepine hypnotic zolpidem will decrease the frequency of respiratory-related arousals, lower the central apnea-hypopnea index, and widen the CO2 reserve during sleep in patients with CSA compared to no treatment. Participants will complete a night study on a low dose of zolpidem and another night study without zolpidem in a crossover manner. The order of night studies is randomized. The results will help unveil the role of arousals in CSA and the acute effect of zolpidem on CSA severity and the propensity to CSA.

Enrollment

14 patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)>15/hour with CAHI>5/hour, will be included in the experiments.

Exclusion criteria

  • less than 18 years old
  • pregnant or breastfeeding female
  • have severe respiratory disease that require to be on oxygen
  • recent health event that may affect the ability to participate in the study,
  • Body Mass Index (BMI) is >40 kg/m2
  • significant insomnia
  • mental instability
  • recent health event that may affect sleep
  • if at any time the principal investigator (PI) identifies that a certain drug is not suitable, or are unable to use the device that is used to treat sleep apnea, will be not be allowed to participate in the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

14 participants in 2 patient groups

Zolpidem, then No Treatment
Experimental group
Description:
Participants will be administered zolpidem for the first night study, and No Treatment during the second night study.
Treatment:
Other: No Treatment
Drug: Zolpidem
No Treatment, then Zolpidem
Experimental group
Description:
Participants will be administered zolpidem for the second night study, and No Treatment during the first night study.
Treatment:
Other: No Treatment
Drug: Zolpidem

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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