Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346554
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2006-06-28
Brief Title:
To Study the Prevalence of Insomnia in Geriatric COPD Patients Who Are Enrolled in a Pulmonary Rehabilitation Program
Sponsor:
Hackensack Meridian Health
Organization:
Hackensack Meridian Health
Study Overview
Official Title:
To Study the Prevalence of Insomnia in Geriatric COPD Patients Who Are Enrolled in a Pulmonary Rehabilitation Program
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal for COPD patients in pulmonary rehabilitation programs is to improve the quality of life COPD is known to be worse at night as are other respiratory problems such as CHF Saturation is known to get worse nocturnally as well Furthermore these COPD rehabilitation patients tend to be older and increasing age is associated with an increase in the incidence of sleep disorders We suspect that there is an increase in the incidence of sleep disorders in COPD patients We plan to further study these patients using questionnaires A preliminary study was done but the results were not comparable to national statistics We plan to repeat the study only changing the questions to a format comparable to data from the National Sleep Foundation
Detailed Description:
Hackensack University Medical Center Institutional Review Board
PROTOCOL To study the prevalence of insomnia in geriatric COPD patients who are enrolled in a pulmonary rehabilitation program
I OBJECTIVES OF THE STUDY
RATIONALE
The goal for geriatric patients with COPD and enrolled in pulmonary rehabilitation programs is to improve the quality of life COPD is known to be worse at night as are other respiratory problems such as CHF Saturation is known to get worse nocturnally as well Furthermore these COPD rehabilitation patients tend to be older and increasing age is associated with an increase in the incidence of sleep disorders We suspect that there is an increase in the incidence of difficulty initiating and maintaining sleep in COPD patients A preliminary study was done by the chest medicine specialist in our group but the results were not comparable to national statistics and were inconclusive We plan to further evaluate the geriatric COPD patients in pulmonary rehabilitation with initial screening questionnaire and diagnostic screening questionnaires MMSE Becks Anxiety Inventory Becks Depression Inventory and Epworth Sleepiness Scale
GOALS
To determine the incidence and prevalence of insomnia difficulty initiating sleep DIS andor difficulty maintaining sleep DMS in the geriatric population with COPD in a rehabilitation program
To determine how many of these patients suffer from anxiety andor depression
HYPOTHESIS
The incidence of insomnia DIS andor DMS along with anxietydepression is more prevalent in geriatric patients with COPD
II BACKGROUND MATERIAL According to the American Academy of Sleep Medicine AASM over a six-month period 20 million Americans complained of insomnia
COPD patients tend to have decreased total sleep time 32 reported total sleep time less than 6 hours According to previous studies conducted the following was reported
15 reported to have insomnia
28 reported poor quality sleep due to anxiety andor depression
12 reported 3 awakenings due to unknown origin
RESULTS OF PILOT
In the pilot study a preliminary general initial questionnaire was used and will continue to be used as a tool for general screening purposes And diagnostic questionnaires will be used which are the following
Becks Anxiety Inventory
Becks Depression Inventory
Epworth Sleepiness Scale
MMSE
III DRUG INFORMATION
No drugs are used in this study protocol
IV INCLUSIONARY CRITERIA
Geriatric patients with COPD enrolled in the rehabilitation program with FEV160
V EXCLUSIONARY CRITERIA
Geriatric patients without a clear diagnosis of COPD Geriatric patients whose FEV160 Geriatric patients who are unable to answer the questionnaire
VI RECRUITMENT PROCEDURES
Geriatric patients in the HUMC pulmonary rehabilitation program who consent to answer the questionnaire and with an FEV160 will be enrolled
VII METHODOLOGY
Screening Charts will be reviewed to see which patients meet the criteria of the study
Informed Consent If the patient is eligible for diagnostic screening then an informed consent will be taken
Randomization None
Baseline evaluation Geriatric patients will be asked the questions in the questionnaire
Follow-up If insomnia is found patient will be referred for further treatment
Withdrawal and Termination The patient is unable to complete the questionnaire
VIII DISCOMFORT AND RISKS
No direct risks to the patient Failure to follow-up in the clinic if indicated could be problematic
IX BENEFITS
Recognition and treatment of sleep problems in this group of patients will add to our understanding of problems in COPD
X CRITERIA FOR EVALUATING RESPONSE
No response anticipated from the study protocol
XI CONFIDENTIALITY
All results will be kept confidential Data will only be used by the investigators Data can be reviewed by the IRB at any time HIPPA forms will be used for the patients permission
XII PRIMARY INVESTIGATOR
Hormoz Ashtyani MD
CO PRIMARY INVESTIGATOR
Susan Zafarlotfi PhD
GERIATRIC MEDICINE SPECIALIST
Knight R Steel MD
RESEARCH COORDINATOR
Mohammad Quadri MD MBA RPSGT
PROTOCOL To study the prevalence of insomnia in geriatric COPD patients who are enrolled in a pulmonary rehabilitation program
I OBJECTIVES OF THE STUDY
RATIONALE
The goal for geriatric patients with COPD and enrolled in pulmonary rehabilitation programs is to improve the quality of life COPD is known to be worse at night as are other respiratory problems such as CHF Saturation is known to get worse nocturnally as well Furthermore these COPD rehabilitation patients tend to be older and increasing age is associated with an increase in the incidence of sleep disorders We suspect that there is an increase in the incidence of difficulty initiating and maintaining sleep in COPD patients A preliminary study was done by the chest medicine specialist in our group but the results were not comparable to national statistics and were inconclusive We plan to further evaluate the geriatric COPD patients in pulmonary rehabilitation with initial screening questionnaire and diagnostic screening questionnaires MMSE Becks Anxiety Inventory Becks Depression Inventory and Epworth Sleepiness Scale
GOALS
To determine the incidence and prevalence of insomnia difficulty initiating sleep DIS andor difficulty maintaining sleep DMS in the geriatric population with COPD in a rehabilitation program
To determine how many of these patients suffer from anxiety andor depression
HYPOTHESIS
The incidence of insomnia DIS andor DMS along with anxietydepression is more prevalent in geriatric patients with COPD
II BACKGROUND MATERIAL According to the American Academy of Sleep Medicine AASM over a six-month period 20 million Americans complained of insomnia
COPD patients tend to have decreased total sleep time 32 reported total sleep time less than 6 hours According to previous studies conducted the following was reported
15 reported to have insomnia
28 reported poor quality sleep due to anxiety andor depression
12 reported 3 awakenings due to unknown origin
RESULTS OF PILOT
In the pilot study a preliminary general initial questionnaire was used and will continue to be used as a tool for general screening purposes And diagnostic questionnaires will be used which are the following
Becks Anxiety Inventory
Becks Depression Inventory
Epworth Sleepiness Scale
MMSE
III DRUG INFORMATION
No drugs are used in this study protocol
IV INCLUSIONARY CRITERIA
Geriatric patients with COPD enrolled in the rehabilitation program with FEV160
V EXCLUSIONARY CRITERIA
Geriatric patients without a clear diagnosis of COPD Geriatric patients whose FEV160 Geriatric patients who are unable to answer the questionnaire
VI RECRUITMENT PROCEDURES
Geriatric patients in the HUMC pulmonary rehabilitation program who consent to answer the questionnaire and with an FEV160 will be enrolled
VII METHODOLOGY
Screening Charts will be reviewed to see which patients meet the criteria of the study
Informed Consent If the patient is eligible for diagnostic screening then an informed consent will be taken
Randomization None
Baseline evaluation Geriatric patients will be asked the questions in the questionnaire
Follow-up If insomnia is found patient will be referred for further treatment
Withdrawal and Termination The patient is unable to complete the questionnaire
VIII DISCOMFORT AND RISKS
No direct risks to the patient Failure to follow-up in the clinic if indicated could be problematic
IX BENEFITS
Recognition and treatment of sleep problems in this group of patients will add to our understanding of problems in COPD
X CRITERIA FOR EVALUATING RESPONSE
No response anticipated from the study protocol
XI CONFIDENTIALITY
All results will be kept confidential Data will only be used by the investigators Data can be reviewed by the IRB at any time HIPPA forms will be used for the patients permission
XII PRIMARY INVESTIGATOR
Hormoz Ashtyani MD
CO PRIMARY INVESTIGATOR
Susan Zafarlotfi PhD
GERIATRIC MEDICINE SPECIALIST
Knight R Steel MD
RESEARCH COORDINATOR
Mohammad Quadri MD MBA RPSGT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None