- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01512771
The Effect of Nasal Continuous Positive Airway Pressure Treatment on PTSD Symptoms. (PTSD)
The Effect of Nasal Continuous Positive Airway Pressure (Nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Design: This is a pilot study to study the effect of nasal CPAP on the symptoms of PTSD in veterans.
Recruitment Methods:
Veterans with PTSD will be recruited from the Northport VAMC PTSD unit. The ACOS/Mental Health will refer patients that meet inclusion criteria and do not have an impaired decision making capacity. Subjects will be screened for decision-making capacity by their treating psychiatrist as part of their clinical assessment upon admission to the PTSD unit.
Study Methods
This will be a prospective, randomized, controlled interventional trial:
- Participants will undergo a routine clinical sleep study at the PTSD unit (using a portable polysomnographic recording unit). or undergo a routine clinical polysomnography to diagnose sleep disordered breathing
Participants who demonstrate SDB will be randomized into two groups based upon their body mass index
- Group A: BMI < 30 kg/m2
- Group B: BMI > 30 kg/m2 The reason for these two arms is to study the effect of nasal CPAP upon PTSD symptoms in veterans with a high prevalence of sleep apnea ( BMI above 30 kg/m2) and in veterans with predominantly snoring (BMI below 30 kg/m2).
Each group will then be randomized into two sub-groups regarding treatment.
- Treatment group receives an automated CPAP unit to use during sleep for 6 weeks in conjunction with their usual care in the PTSD unit (psychotherapy).
- Control group receives the usual care that is provided in the PTSD unit for 6 weeks (change in medications will exclude the subject from the study), if any participant in the control group would like to try nasal CPAP, then he will be crossed over to use an automated CPAP unit during sleep for his second 6 weeks in the PTSD unit together with usual care.
All participants will fill out the following questionnaires at baseline and after 6 weeks. (Those in the control group who have been crossed-over to nasal CPAP will also fill out a set of questionnaire at 12 weeks).
- PTSD checklist-military version (anxiety)
- MASQ anxious arousal subscale (anxiety)
- Insomnia Severity Index (insomnia)
- The alcohol craving questionnaire (with an alcohol history during the intake) The changes in patient's reported outcomes will be compared before and after CPAP treatment and psychotherapy alone
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
New York
-
Northport, New York, Forente stater, 11768
- PTSD unit at Northport VAMC
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
A. Admitted to PTSD unit at NVAMC and will remain in the unit for at least 12 weeks after initiation of study participation.
B. Found to have SDB by polysomnography
Exclusion Criteria:
- Impaired Decision-Making Capacity, as determined by treating psychiatrist.
- No sleep disordered breathing found by polysomnography
- Unable/unwilling to use the nasal CPAP
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Crossover
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.
Tidsramme: six weeks of nasal CPAP
|
A comparison of the effectiveness of six weeks of nasal CPAP plus usual care to usual care alone at decreasing the symptoms of PTSD (anxiety, insomnia and alcohol craving) among veterans with PTSD and SDB
|
six weeks of nasal CPAP
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.
Tidsramme: 6 weeks of nasal CPAP
|
A comparison of the change in symptoms to the change in the total of sleep stage shifts during sleep for all patients with PTSD and SDB participating in the study.
|
6 weeks of nasal CPAP
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Mohammad Amin, MD, Northport VAMC
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 00383
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .